## Protocol Section
### Identification Module
**NCT ID:** NCT00671879

**Brief Title:** Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back

**Official Title:** Randomized, Double-Blind, Double-Dummy Trial of Two Sustained Release Formulations of Carisoprodol Compared to Placebo in Subjects With Acute, Painful, Musculoskeletal Spasm of the Lower Back

#### Organization Study ID Info
**ID:** MP511
#### Organization
**Class:** INDUSTRY
**Full Name:** Meda Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2009-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-11-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-10-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-03

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2012-11-21

**Type:** ESTIMATED

**Results First Submit Date:** 2011-07-13

**Results First Submit QC Date:** 2012-10-22

#### Start Date
**Date:** 2008-04

**Status Verified Date:** 2012-10

#### Study First Post Date
**Date:** 2008-05-05
**Type:** ESTIMATED
**Study First Submit Date:** 2008-05-01
**Study First Submit QC Date:** 2008-05-02
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Meda Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.

**Detailed Description:** Methodology:

This will be a randomized, double-blind, double-dummy, placebo-controlled, parallel-group study in subjects 18-70 years of age with acute, painful, muscle spasm of the lower back. The study consists of a baseline screening (Study Day 1), during which subjects will be evaluated for inclusion/exclusion criteria, and a 7-day double-blind treatment period (Study Day 1 through Study Day 7). Subjects will be randomly assigned to be dosed twice daily with one of the following double-blind treatments: SR carisoprodol 500-mg tablets, SR carisoprodol 700-mg tablets, or placebo.

Subjects will be evaluated in the clinic on Study Days 1, 3 and 7. Subjects who remain symptomatic on Study Day 7 will be allowed to continue in the study for a 7-day, double-blind extension period at the discretion of the Investigator. Subjects will be contacted by telephone for a safety follow-up 7 days after the last dose of study medication.

A pharmacokinetic (PK) substudy will be conducted at selected sites. These sites will obtain blood samples for PK analysis at the end of the 7-day treatment period and the 14-day treatment period, if applicable.

### Conditions Module

**Conditions:**

- Lower Back Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 830

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Carisoprodol 700 mg twice daily

**Intervention Names:**

- Drug: Carisoprodol SR 700 mg

**Label:** Carisprodol SR 700 mg

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Carisoprodol SR 500 mg twice daily

**Intervention Names:**

- Drug: Carisoprodol SR 500 mg

**Label:** Carisoprodol SR 500mg

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Placebo

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Carisprodol SR 700 mg

**Description:** 700 mg twice daily tablet

**Name:** Carisoprodol SR 700 mg

**Other Names:**

- no other name

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Carisoprodol SR 500mg

**Description:** carisoprodol SR 500 mg tablet

**Name:** Carisoprodol SR 500 mg

**Other Names:**

- no other name

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Placebo

**Description:** placebo tablet

**Name:** Placebo

**Other Names:**

- no other name

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** on a visual analog scale of 0 to 100 millimeters(mm) with 0 being no pain and 100 being maximum pain By measuring the amount of pain before and during treatment done at each visit and recording the difference in mm.During treatment scores were averaged and this average was compared to the baseline value.

**Measure:** Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale

**Time Frame:** baseline to 14 days

#### Secondary Outcomes

**Description:** Subject functional assessment based on the Roland-Morris Disability Questionnaire (RMDQ)at day 14.Subjects were asked to read a list of 24 sentences that people have used to describe themselves when they had back pain, and were asked to mark those statements that described their condition that day. The number of marked statements was added. A decrease in the number of marked statements from baseline represented improvement on the RMDQ.

**Measure:** Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)

**Time Frame:** baseline and day +14

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Onset of pain is within 3 days of first visit
* Subject rating of pain must be 40 mm or greater on VAS
* Ability to discontinue all analgesics, NSAIDs, and other muscle relaxants
* Willingness to provide written informed consent
* Must be in generally good health

Exclusion Criteria:

* Presence of sciatic pain
* History of clinically significant spine pathology such as herniated nucleus pulpous, spondylolisthesis, spinal stenosis
* Presence of underlying chronic back pain
* Neurological signs and symptoms such as numbness, tingling, foot drop, paresthesia, unexplained constipation, urinary retention or urinary incontinence
* Myocardial infarction within one year of study
* Cancer not in remission or in remission less than one year
* HIV or other immunodeficiency syndromes
* History of osteoporosis or at high risk for vertebral fracture
* Underlying rheumatologic disease such as rheumatoid arthritis, ankylosing spondylitis, etc.
* Presence of active influenza or other viral syndromes
* Morbid obesity (BMI \>39)
* Evidence of infection, such as low grade fever or neutrophilia
* Existence of any medical/surgical condition that could interfere with the evaluation of the study medication
* Known history of alcohol or drug abuse
* Injury involving high potential for litigation, including worker's compensation or automobile accidents
* Pregnancy or breast feeding
* Women of child-bearing potential not abstinent or not practicing a medically acceptable method of contraception
* Vertebral body or spinous process, percussive tenderness on physical exam
* Any abnormalities in the following tests of both lower extremities: ankle dorsiflexion strength, great toe dorsiflexion strength, absent or hyperreflexic Achilles or patellar tendor reflexes, abnormal sensory exam in the medial, dorsal or lateral aspect of the foot and positive straight leg raise test
* Urgent medical conditions on comprehensive exam that might indicate a more serious condition should be treated urgently

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**Facility:** Brookwood Internists, P.C.

**State:** Alabama

**Zip:** 35209

**Location 2:**

**City:** Gulf Shores

**Country:** United States

**Facility:** Gulf Shores General Practice Center

**State:** Alabama

**Zip:** 36547

**Location 3:**

**City:** Hueytown

**Country:** United States

**Facility:** Simon Williamson Clinic, PC

**State:** Alabama

**Zip:** 35023

**Location 4:**

**City:** Montgomery

**Country:** United States

**Facility:** Vaugh H Mancha Jr., PC Family Practice

**State:** Alabama

**Zip:** 36117

**Location 5:**

**City:** Phoenix

**Country:** United States

**Facility:** NextCare Institute for Clinical Research

**State:** Arizona

**Zip:** 85016

**Location 6:**

**City:** Phoenix

**Country:** United States

**Facility:** HOPE Research Institute

**State:** Arizona

**Zip:** 85050

**Location 7:**

**City:** Tempe

**Country:** United States

**Facility:** Fiel Family and Sports Medicine

**State:** Arizona

**Zip:** 85283

**Location 8:**

**City:** Little Rock

**Country:** United States

**Facility:** Lynn Institute of the Ozarks

**State:** Arkansas

**Zip:** 72205

**Location 9:**

**City:** Anaheim

**Country:** United States

**Facility:** Quality of life Medical, LLC

**State:** California

**Zip:** 92801

**Location 10:**

**City:** Beverly Hills

**Country:** United States

**Facility:** ICT - Beverly Hills

**State:** California

**Zip:** 90211

**Location 11:**

**City:** Burbank

**Country:** United States

**Facility:** Lovelace Scientific Resources, Inc.

**State:** California

**Zip:** 91506

**Location 12:**

**City:** Inglewood

**Country:** United States

**Facility:** Chrishard Medical Group

**State:** California

**Zip:** 90301

**Location 13:**

**City:** Los Angeles

**Country:** United States

**Facility:** Impact Clinical Trials and Powerplay

**State:** California

**Zip:** 90036

**Location 14:**

**City:** Newport Beach

**Country:** United States

**Facility:** Newport Beach Clinical Research Associates, Inc.

**State:** California

**Zip:** 92660

**Location 15:**

**City:** San Diego

**Country:** United States

**Facility:** San Diego Managed Care Group

**State:** California

**Zip:** 92128

**Location 16:**

**City:** Santa Ana

**Country:** United States

**Facility:** Crest Clinical Trials, Inc.

**State:** California

**Zip:** 92701

**Location 17:**

**City:** Santa Barbara

**Country:** United States

**Facility:** Santa Barbara Clinical Research Inc.

**State:** California

**Zip:** 93108

**Location 18:**

**City:** Colorado Springs

**Country:** United States

**Facility:** Clinicos, LLC

**State:** Colorado

**Zip:** 80904

**Location 19:**

**City:** Denver

**Country:** United States

**Facility:** Horizons Clinical Research Center, LLC

**State:** Colorado

**Zip:** 80220

**Location 20:**

**City:** Clearwater

**Country:** United States

**Facility:** Tampa Bay Medical Research

**State:** Florida

**Zip:** 33761

**Location 21:**

**City:** Daytona Beach

**Country:** United States

**Facility:** Atlantic Institute of Clinical Research

**State:** Florida

**Zip:** 32114

**Location 22:**

**City:** Gainesville

**Country:** United States

**Facility:** Florida Research Network, LLC

**State:** Florida

**Zip:** 32605

**Location 23:**

**City:** Hollywood

**Country:** United States

**Facility:** Orthopaedic Assoc. of S. Broward, P.A.

**State:** Florida

**Zip:** 33021

**Location 24:**

**City:** Kissimmee

**Country:** United States

**Facility:** FPA Clinical Research

**State:** Florida

**Zip:** 34741

**Location 25:**

**City:** Lakeland

**Country:** United States

**Facility:** Jay Care Medical Center

**State:** Florida

**Zip:** 33805

**Location 26:**

**City:** Largo

**Country:** United States

**Facility:** Innovative Research of West FL, Inc.

**State:** Florida

**Zip:** 33770

**Location 27:**

**City:** Melbourne

**Country:** United States

**Facility:** Oslar Medical, Inc./ Osler Clinical Research

**State:** Florida

**Zip:** 32901

**Location 28:**

**City:** Naranja

**Country:** United States

**Facility:** Homestead Clinical Research

**State:** Florida

**Zip:** 33032

**Location 29:**

**City:** Pembroke Pines

**Country:** United States

**Facility:** Andres Patron, DO, PA

**State:** Florida

**Zip:** 33026

**Location 30:**

**City:** St. Cloud

**Country:** United States

**Facility:** Wilker/Powers Center for Clinical Studies

**State:** Florida

**Zip:** 34769

**Location 31:**

**City:** Tampa

**Country:** United States

**Facility:** Orlando Rangel, M.D., P.A.

**State:** Florida

**Zip:** 33607

**Location 32:**

**City:** Tampa

**Country:** United States

**Facility:** West Wind'r Research & Development, LLC

**State:** Florida

**Zip:** 33607

**Location 33:**

**City:** West Palm Beach

**Country:** United States

**Facility:** Palm Beach Research center

**State:** Florida

**Zip:** 33409

**Location 34:**

**City:** Atlanta

**Country:** United States

**Facility:** PMI Health Research Group

**State:** Georgia

**Zip:** 30312

**Location 35:**

**City:** Atlanta

**Country:** United States

**Facility:** Perimeter Institute for Clinical Research, Inc.

**State:** Georgia

**Zip:** 30338

**Location 36:**

**City:** Decatur

**Country:** United States

**Facility:** Best Clinical Research

**State:** Georgia

**Zip:** 30034

**Location 37:**

**City:** Naperville

**Country:** United States

**Facility:** Dupage Family Medicine

**State:** Illinois

**Zip:** 60564

**Location 38:**

**City:** Wichita

**Country:** United States

**Facility:** Heartland Research Associates, LLC

**State:** Kansas

**Zip:** 67205

**Location 39:**

**City:** Lexington

**Country:** United States

**Facility:** Bluegrass Orthopaedics & Hand Care Research

**State:** Kentucky

**Zip:** 40509

**Location 40:**

**City:** Lexington

**Country:** United States

**Facility:** Central Kentucky Research Associates, Inc.

**State:** Kentucky

**Zip:** 40509

**Location 41:**

**City:** New Orleans

**Country:** United States

**Facility:** Clinical Research Institute

**State:** Louisiana

**Zip:** 70128

**Location 42:**

**City:** Shreveport

**Country:** United States

**Facility:** Highland Clinic, APMC

**State:** Louisiana

**Zip:** 71105

**Location 43:**

**City:** Waterford

**Country:** United States

**Facility:** Waterford Medical Associates

**State:** Michigan

**Zip:** 48328

**Location 44:**

**City:** Jackson

**Country:** United States

**Facility:** CRC of Jackson

**State:** Mississippi

**Zip:** 39202

**Location 45:**

**City:** Omaha

**Country:** United States

**Facility:** Quality Clinical Research, Inc.

**State:** Nebraska

**Zip:** 68114

**Location 46:**

**City:** Omaha

**Country:** United States

**Facility:** Dr. Meera Dewan PC

**State:** Nebraska

**Zip:** 68144

**Location 47:**

**City:** Las Vegas

**Country:** United States

**Facility:** Association of International Professionals

**State:** Nevada

**Zip:** 89101

**Location 48:**

**City:** Las Vegas

**Country:** United States

**Facility:** ICT - Las Vegas

**State:** Nevada

**Zip:** 89106

**Location 49:**

**City:** Bloomfield

**Country:** United States

**Facility:** Immedicenter

**State:** New Jersey

**Zip:** 07003

**Location 50:**

**City:** West Caldwell

**Country:** United States

**Facility:** Land Clinical Studies

**State:** New Jersey

**Zip:** 07006

**Location 51:**

**City:** New York

**Country:** United States

**Facility:** Research Across America

**State:** New York

**Zip:** 10022

**Location 52:**

**City:** Fargo

**Country:** United States

**Facility:** Odyssey Research

**State:** North Dakota

**Zip:** 58104

**Location 53:**

**City:** Columbus

**Country:** United States

**Facility:** Parsons Avenue Medical Clinic

**State:** Ohio

**Zip:** 43207

**Location 54:**

**City:** Dayton

**Country:** United States

**Facility:** Dayton Clinical Research

**State:** Ohio

**Zip:** 45406

**Location 55:**

**City:** Oklahoma City

**Country:** United States

**Facility:** Hillcrest Clinical Research

**State:** Oklahoma

**Zip:** 73119

**Location 56:**

**City:** Harleysville

**Country:** United States

**Facility:** Harleysville Medical Associates

**State:** Pennsylvania

**Zip:** 19438

**Location 57:**

**City:** Warminster

**Country:** United States

**Facility:** Warminster Medical Association

**State:** Pennsylvania

**Zip:** 18974

**Location 58:**

**City:** Greer

**Country:** United States

**Facility:** DeGarmo Institute of Medical Research

**State:** South Carolina

**Zip:** 29651

**Location 59:**

**City:** Pelzer

**Country:** United States

**Facility:** Palmetto Family Medicine Center

**State:** South Carolina

**Zip:** 29669

**Location 60:**

**City:** Kingsport

**Country:** United States

**Facility:** Holston Medical Group, P.C.

**State:** Tennessee

**Zip:** 37660

**Location 61:**

**City:** Arlington

**Country:** United States

**Facility:** Medical Clinic of North Texas

**State:** Texas

**Zip:** 76012

**Location 62:**

**City:** Austin

**Country:** United States

**Facility:** Central Texas Clinical Research

**State:** Texas

**Zip:** 78705

**Location 63:**

**City:** Bryan

**Country:** United States

**Facility:** DiscoveResearch, Inc.

**State:** Texas

**Zip:** 77802

**Location 64:**

**City:** Colleyville

**Country:** United States

**Facility:** Texas Family Care Clinical Research

**State:** Texas

**Zip:** 76034

**Location 65:**

**City:** Dallas

**Country:** United States

**Facility:** Research Across America

**State:** Texas

**Zip:** 75234

**Location 66:**

**City:** Georgetown

**Country:** United States

**Facility:** Georgetown Medical Clinic

**State:** Texas

**Zip:** 78626

**Location 67:**

**City:** Houston

**Country:** United States

**Facility:** F. Adam Kawley, MD PA

**State:** Texas

**Zip:** 77024

**Location 68:**

**City:** New Braunfels

**Country:** United States

**Facility:** Central Texas Health Research

**State:** Texas

**Zip:** 78130

**Location 69:**

**City:** San Antonio

**Country:** United States

**Facility:** GSA Research

**State:** Texas

**Zip:** 78213

**Location 70:**

**City:** San Antonio

**Country:** United States

**Facility:** Sun Research Institute

**State:** Texas

**Zip:** 78215

**Location 71:**

**City:** San Antonio

**Country:** United States

**Facility:** Sylvana Research Associates

**State:** Texas

**Zip:** 78229

**Location 72:**

**City:** Sugar Land

**Country:** United States

**Facility:** Clinical Health Research, LLC

**State:** Texas

**Zip:** 77479

**Location 73:**

**City:** Weber City

**Country:** United States

**Facility:** Holston Medical Group, P.C.

**State:** Virginia

**Zip:** 24290

#### Overall Officials

**Official 1:**

**Affiliation:** Meda Pharmaceuticals

**Name:** Lewis M. Fredane, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001416

- Term: Back Pain

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4714

- Name: Back Pain

- Relevance: LOW

- As Found: Unknown

- ID: M19433

- Name: Low Back Pain

- Relevance: HIGH

- As Found: Lower Back Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M15837

- Name: Spasm

- Relevance: LOW

- As Found: Unknown

- ID: M12077

- Name: Muscle Cramp

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000017116

- Term: Low Back Pain

### Intervention Browse Module - Ancestors

- ID: D000009125

- Term: Muscle Relaxants, Central

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000009465

- Term: Neuromuscular Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: MuRelCen

- Name: Muscle Relaxants, Central

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5583

- Name: Carisoprodol

- Relevance: HIGH

- As Found: Cognitive Fatigue

### Intervention Browse Module - Meshes

- ID: D000002328

- Term: Carisoprodol

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Carisprodol SR 700 mg

**Description:** Carisoprodol 700 mg twice daily

**ID:** EG000

**Other Num Affected:** 98

**Other Num at Risk:** 281

**Serious Number At Risk:** 281

**Title:** Carisprodol SR 700 mg

**Group ID:** EG001

**Title:** Carisoprodol SR 500mg

**Description:** Carisoprodol SR 500 mg twice daily

**ID:** EG001

**Other Num Affected:** 94

**Other Num at Risk:** 275

**Serious Number Affected:** 3

**Serious Number At Risk:** 275

**Title:** Carisoprodol SR 500mg

**Group ID:** EG002

**Title:** Placebo

**Description:** Placebo treatment arm

**ID:** EG002

**Other Num Affected:** 49

**Other Num at Risk:** 274

**Serious Number At Risk:** 274

**Title:** Placebo

**Frequency Threshold:** 0.4

#### Other Events

**Term:** somnolence

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA

**Term:** headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (10.0)

**Term:** dizziness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (10.0)

**Term:** nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA

**Term:** fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA

**Term:** increased blood CPK

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA

**Term:** insomnia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA

**Term:** constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA

**Term:** diarrhea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA

**Term:** dry mouth

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA

**Term:** vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA

**Term:** Lasegues Test Positive

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA

**Term:** anxiety

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA

**Term:** clumsiness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA

**Term:** pain in extremity

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA

#### Serious Events

**Term:** atypical pneumonitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (11.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 281

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 275

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 274

**Term:** stroke

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (11.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 281

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 275

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 274

**Term:** severe influenza

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (11.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 281

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 275

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 274

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 281

**Group ID:** BG001

**Value:** 279

**Group ID:** BG002

**Value:** 280

**Group ID:** BG003

**Value:** 840

**Units:** Participants

### Group

**ID:** BG000

**Title:** Carisprodol SR 700 mg

**Description:** Carisoprodol 700 mg twice daily

### Group

**ID:** BG001

**Title:** Carisoprodol SR 500mg

**Description:** Carisoprodol SR 500 mg twice daily

### Group

**ID:** BG002

**Title:** Placebo

**Description:** Placebo treatment arm

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 279

#### Measurement

**Group ID:** BG001

**Value:** 279

#### Measurement

**Group ID:** BG002

**Value:** 280

#### Measurement

**Group ID:** BG003

**Value:** 838

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 2

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.35

**Value:** 41.5

#### Measurement

**Group ID:** BG001

**Spread:** 11.79

**Value:** 41.6

#### Measurement

**Group ID:** BG002

**Spread:** 11.86

**Value:** 41.4

#### Measurement

**Group ID:** BG003

**Spread:** 12.0

**Value:** 41.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 149

#### Measurement

**Group ID:** BG001

**Value:** 145

#### Measurement

**Group ID:** BG002

**Value:** 144

#### Measurement

**Group ID:** BG003

**Value:** 438

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 132

#### Measurement

**Group ID:** BG001

**Value:** 134

#### Measurement

**Group ID:** BG002

**Value:** 136

#### Measurement

**Group ID:** BG003

**Value:** 402

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 281

#### Measurement

**Group ID:** BG001

**Value:** 279

#### Measurement

**Group ID:** BG002

**Value:** 280

#### Measurement

**Group ID:** BG003

**Value:** 840

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** david.ginsberg@meda.us
**Organization:** Meda Pharma US
**Phone:** 732 564 2347
**Title:** David Ginsberg, DO Sr Dir Medical Scientific Affairs
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.30
- **Upper Limit:** 
- **Value:** 16.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.34
- **Upper Limit:** 
- **Value:** 15.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.32
- **Upper Limit:** 
- **Value:** 15.2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.64
- **Upper Limit:** 
- **Value:** 4.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.64
- **Upper Limit:** 
- **Value:** 5.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.65
- **Upper Limit:** 
- **Value:** 4.3
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** on a visual analog scale of 0 to 100 millimeters(mm) with 0 being no pain and 100 being maximum pain By measuring the amount of pain before and during treatment done at each visit and recording the difference in mm.During treatment scores were averaged and this average was compared to the baseline value.
**Dispersion Type:** Standard Deviation
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** intent to treat(ITT) population least square mean(LSMEAN, LSMEAN) diff vs Placebo
**Reporting Status:** POSTED
**Time Frame:** baseline to 14 days
**Title:** Subject Rated Change Relief From Starting Backache of Pain on a 100-point Visual Analog Scale
**Type:** PRIMARY
**Unit of Measure:** mm
##### Group
**Description:** Carisoprodol SR 700 mg twice daily
**ID:** OG000
**Title:** Carisprodol SR 700 mg
##### Group
**Description:** Carisoprodol SR 500 mg twice daily
**ID:** OG001
**Title:** Carisoprodol SR 500mg
##### Group
**Description:** Placebo treatment arm
**ID:** OG002
**Title:** Placebo
#### Outcome Measure 2
**Description:** Subject functional assessment based on the Roland-Morris Disability Questionnaire (RMDQ)at day 14.Subjects were asked to read a list of 24 sentences that people have used to describe themselves when they had back pain, and were asked to mark those statements that described their condition that day. The number of marked statements was added. A decrease in the number of marked statements from baseline represented improvement on the RMDQ.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Intent to Treat(ITT) population
**Reporting Status:** POSTED
**Time Frame:** baseline and day +14
**Title:** Subject Functional Assessment Based on the Roland-Morris Disability Questionnaire (RMDQ)
**Type:** SECONDARY
**Unit of Measure:** marked statements
##### Group
**Description:** Carisoprodol 700 mg twice daily
**ID:** OG000
**Title:** Carisprodol SR 700 mg
##### Group
**Description:** Carisoprodol SR 500 mg twice daily
**ID:** OG001
**Title:** Carisoprodol SR 500mg
##### Group
**Description:** Placebo treatment arm
**ID:** OG002
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Carisoprodol 700 mg twice daily
**ID:** FG000
**Title:** Carisprodol SR 700 mg
#### Group
**Description:** Carisoprodol SR 500 mg twice daily
**ID:** FG001
**Title:** Carisoprodol SR 500mg
#### Group
**Description:** Placebo treatment arm
**ID:** FG002
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
###### Reason
**Group ID:** FG002
**Number of Subjects:** 6
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 281
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 279
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 280
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 281
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 275
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 274
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 6
**Has Results:** True