## Protocol Section
### Identification Module
**NCT ID:** NCT01471379

**Brief Title:** Milnacipran (Savella) in Irritable Bowel Syndrome (IBS)

**Official Title:** A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Milnacipran in the Treatment of Irritable Bowel Syndrome

#### Organization Study ID Info
**ID:** 11-1105a
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
### Status Module
#### Completion Date
**Date:** 2013-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-04-13

**Type:** ACTUAL

**Last Update Submit Date:** 2017-03-15

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2013-02

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2013-12-24

**Type:** ESTIMATED

**Results First Submit Date:** 2013-07-03

**Results First Submit QC Date:** 2013-11-05

#### Start Date
**Date:** 2012-04

**Status Verified Date:** 2017-03

#### Study First Post Date
**Date:** 2011-11-16
**Type:** ESTIMATED
**Study First Submit Date:** 2011-11-10
**Study First Submit QC Date:** 2011-11-14
**Why Stopped:** Due to recruitment difficulties the study is terminated.
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Forest Laboratories

#### Lead Sponsor

**Class:** OTHER

**Name:** Spencer Dorn, MD, MPH

#### Responsible Party

**Investigator Affiliation:** University of North Carolina, Chapel Hill

**Investigator Full Name:** Spencer Dorn, MD, MPH

**Investigator Title:** Assistant Professor of Medicine

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Purpose: The investigators are proposing to examine the use of Savella® (Milnacipran) for treating irritable bowel syndrome (IBS) in women.

Participants: Eligible participants will meet the Rome III diagnostic criteria for IBS.

Procedures: This study will observe patients treated with Savella® as well as patients treated with a placebo (pill with no active drug). The investigators will monitor and compare several patient and symptom related outcomes, as well as evaluate health related quality of life, psychological distress and related psychosocial measures to determine if the addition of Savella® improves clinical pain response as well as secondary outcomes including quality of life.

**Detailed Description:** Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized primarily by abdominal pain associated with bowel dysfunction. Like many other painful functional somatic syndromes (e.g. fibromyalgia) the pathophysiology of IBS includes abnormal responses to pain and dysregulation of brain-body pain pathways. IBS affects up to 10% of the population, is a leading reason for visits to gastroenterologists and primary care doctors, and, in the United States, annually accrues health care costs over $20 billion.

In their practice the investigators use centrally acting agents to treat IBS. Historically, the investigators have used tricyclic antidepressants based on results of clinical trials, including our NIH funded trial on desipramine. Nonetheless, these agents can produce side effects that limit their full application. More recently the investigators have begun to use SNRIs because they have been shown to benefit for various pain syndromes like diabetic neuropathy, fibromyalgia. The initial impression is that Milnacipran helps improve IBS symptoms and global well being. There is now a need to systematically determine Milnacipran's value for IBS.

### Conditions Module

**Conditions:**

- Irritable Bowel Syndrome

**Keywords:**

- Irritable Bowel Syndrome

- IBS

- Savella

- Milnacipran

- Abdominal Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 2

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II

**Intervention Names:**

- Drug: Milnacipran

**Label:** Group A (50mg - 100mg)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.

**Intervention Names:**

- Drug: Milnacipran

**Label:** Group B (50mg x12)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II

**Intervention Names:**

- Drug: Milnacipran

- Drug: Placebo

**Label:** Group C (Placebo - 50mg)

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A (50mg - 100mg)

- Group C (Placebo - 50mg)

**Description:** 50mg Milnacipran PO, BID, for 6 weeks.

**Name:** Milnacipran

**Other Names:**

- Savella

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Group A (50mg - 100mg)

**Description:** Milnacipran, 100mg PO, BID, for six weeks

**Name:** Milnacipran

**Other Names:**

- Savella

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Group B (50mg x12)

**Description:** Milnacipran, 50mg PO BID for 12 weeks

**Name:** Milnacipran

**Other Names:**

- Savella

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Group C (Placebo - 50mg)

**Description:** Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain before the beginning of the study, at 6 weeks of treatment and at the end visit i.e. 10 weeks. Ideally, VAS would have been administered at the 12th week; however, subject was terminated at the 10th week visit. A positive pain response (ie pain relief) was defined as \>30% decrease in the VAS score between baseline and the final study visit.

**Measure:** Number of Participants With Pain Response

**Time Frame:** Twelve Weeks

#### Secondary Outcomes

**Description:** After six weeks of treatment with Milnacipran, treatment groups were compared with placebo for clinically significant improvement in IBS-QOL. 11 point reduction in IBS-QOL compared to baseline was considered as clinically significant improvement.

**Measure:** Quality of Life ( IBS-QOL)

**Time Frame:** Six Weeks

**Description:** The study sought to determine if the Milnacipran arms had a greater proportion of adequate relief over the placebo group. Subjects were asked to answer 'yes' or 'no' as to whether or not they had adequate relief of pain due to irritable bowel syndrome.

**Measure:** Subject Self Reported Adequate Relief of Pain

**Time Frame:** Twelve Weeks

**Description:** Treatment Efficacy Questionnaire is a measure of treatment effectiveness. The score ranges from 1 to 48, 1 is minimum score and 48 is the maximum score. The investigators was looking to see if the Milnacipran treatment groups have a higher proportion of subjects with significant improvement in efficacy, judged as a TEQ score of \>28, compared to placebo group.

**Measure:** Treatment Efficacy Questionnaire (TEQ)

**Time Frame:** Twelve Weeks

**Description:** The investigator was looking to see if, for group A, when increased from 50 mg BID to 100 mg BID there is significant improvement of pain scores i.e. 30% pain reduction, and for group C, if there was significant improvement of pain scores when switched from placebo to 50 mg BID of Milnacipran

**Measure:** Dose Related Incremental Benefit in Pain Reduction Based on VAS

**Time Frame:** 12 Weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Meet Rome III criteria for IBS and have no red flags.
* Must have had a colonoscopy within the previous 5 years to exclude inflammatory or other bowel disease
* Be fluent and literate in English
* Must either be of non-childbearing potential or agree to utilize approved birth control for the duration of the study

Exclusion Criteria:

* Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening.
* Any other diagnosis to explain the abdominal pain,
* Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurologic, psychiatric or any disease that may interfere with the subject successfully completing the trial
* Hepatic dysfunction (ALT \[SGPT\] or AST \[SGOT\] \>3 times the upper limit of normal) or renal impairment (serum creatinine \> 2mg/dL)
* Has disease affecting electrolytes balance, such as SIADH with serum Sodium less than 130mmol/L
* Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year
* Any surgery on the stomach, small intestine or colon, excluding appendectomy
* A major psychiatric disorder (DSM-III-R or DSM-IV) including major depression or other psychoses that has required hospitalization in the last 1 year.
* History of attempted suicide or uncontrolled bipolar disorder.
* Currently using antidepressants for psychiatric conditions like major depression. Use of TCA or SSRI class antidepressant acceptable if being used specifically for treatment of bowel symptoms and patient is willing to taper off the medication
* Previous use of Milnacipran or other SNRI antidepressant (duloxetine, venlafaxine, desvenlafaxine)
* A diagnosis of seizure disorder
* A diagnosis of glaucoma
* Currently taking heparin or warfarin

**Maximum Age:** 79 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chapel Hill

**Country:** United States

**Facility:** UNC Center for Functional GI and Motility Disorders

**State:** North Carolina

**Zip:** 27599

#### Overall Officials

**Official 1:**

**Affiliation:** University of North Carolina, Chapel Hill

**Name:** Spencer D Dorn, MD, MPH

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000003109

- Term: Colonic Diseases, Functional

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M25118

- Name: Irritable Bowel Syndrome

- Relevance: HIGH

- As Found: Irritable Bowel Syndrome

- ID: M18311

- Name: Abdominal Pain

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6337

- Name: Colonic Diseases, Functional

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000043183

- Term: Irritable Bowel Syndrome

- ID: D000013577

- Term: Syndrome

### Intervention Browse Module - Ancestors

- ID: D000068760

- Term: Serotonin and Noradrenaline Reuptake Inhibitors

- ID: D000014179

- Term: Neurotransmitter Uptake Inhibitors

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000000928

- Term: Antidepressive Agents

- ID: D000011619

- Term: Psychotropic Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

### Intervention Browse Module - Browse Leaves

- ID: M2003

- Name: Milnacipran

- Relevance: HIGH

- As Found: 131I-

- ID: M2015

- Name: Levomilnacipran

- Relevance: HIGH

- As Found: 131I-

- ID: M12575

- Name: Norepinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M305

- Name: Serotonin and Noradrenaline Reuptake Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000078764

- Term: Milnacipran

- ID: D000078862

- Term: Levomilnacipran

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Group A (50mg - 100mg)

**Description:** Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Milnacipran : Milnacipran, 100mg PO, BID, for six weeks

**ID:** EG000

**Other Num Affected:** 1

**Other Num at Risk:** 1

**Serious Number At Risk:** 1

**Title:** Group A (50mg - 100mg)

**Group ID:** EG001

**Title:** Group B (50mg x12)

**Description:** Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.

Milnacipran : Milnacipran, 50mg PO BID for 12 weeks

**ID:** EG001

**Serious Number At Risk:** 1

**Title:** Group B (50mg x12)

**Group ID:** EG002

**Title:** Group C (Placebo - 50mg)

**Description:** Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.

**ID:** EG002

**Title:** Group C (Placebo - 50mg)

**Frequency Threshold:** 1

#### Other Events

**Term:** hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 10.0

**Time Frame:** 3 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 1

**Group ID:** BG001

**Value:** 1

**Group ID:** BG002

**Value:** 0

**Group ID:** BG003

**Value:** 2

**Units:** Participants

### Group

**ID:** BG000

**Title:** Group A (50mg - 100mg)

**Description:** Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Milnacipran : Milnacipran, 100mg PO, BID, for six weeks

### Group

**ID:** BG001

**Title:** Group B (50mg x12)

**Description:** Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.

Milnacipran : Milnacipran, 50mg PO BID for 12 weeks

### Group

**ID:** BG002

**Title:** Group C (Placebo - 50mg)

**Description:** Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.

### 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:** BG003

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 2

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

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0

**Value:** 47

#### Measurement

**Group ID:** BG001

**Spread:** 0

**Value:** 66

#### Measurement

**Group ID:** BG003

**Spread:** 9.5

**Value:** 56.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 2

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 2

**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
**Population Description:** The study was terminated early resulting in a small number of subjects enrolled leaving the ability to analyze only certain categories.
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** sdorn@med.unc.edu
**Organization:** UNC Chapel Hill
**Phone:** 919-966-0141
**Title:** Dr. Spencer Dorn Associate Professor
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 2
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain before the beginning of the study, at 6 weeks of treatment and at the end visit i.e. 10 weeks. Ideally, VAS would have been administered at the 12th week; however, subject was terminated at the 10th week visit. A positive pain response (ie pain relief) was defined as \>30% decrease in the VAS score between baseline and the final study visit.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Twelve Weeks
**Title:** Number of Participants With Pain Response
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** Group A begins treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Milnacipran : Milnacipran, 100mg PO, BID, for six weeks
**ID:** OG000
**Title:** Group A (50mg - 100mg)
##### Group
**Description:** Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.

Milnacipran : Milnacipran, 50mg PO BID for 12 weeks
**ID:** OG001
**Title:** Group B (50mg x12)
##### Group
**Description:** Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.
**ID:** OG002
**Title:** Group C (Placebo - 50mg)
#### Outcome Measure 2
**Description:** After six weeks of treatment with Milnacipran, treatment groups were compared with placebo for clinically significant improvement in IBS-QOL. 11 point reduction in IBS-QOL compared to baseline was considered as clinically significant improvement.
**Reporting Status:** POSTED
**Time Frame:** Six Weeks
**Title:** Quality of Life ( IBS-QOL)
**Type:** SECONDARY
##### Group
**Description:** Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Milnacipran : Milnacipran, 100mg PO, BID, for six weeks
**ID:** OG000
**Title:** Group A (50mg - 100mg)
##### Group
**Description:** Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.

Milnacipran : Milnacipran, 50mg PO BID for 12 weeks
**ID:** OG001
**Title:** Group B (50mg x12)
##### Group
**Description:** Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.
**ID:** OG002
**Title:** Group C (Placebo - 50mg)
#### Outcome Measure 3
**Description:** The study sought to determine if the Milnacipran arms had a greater proportion of adequate relief over the placebo group. Subjects were asked to answer 'yes' or 'no' as to whether or not they had adequate relief of pain due to irritable bowel syndrome.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Twelve Weeks
**Title:** Subject Self Reported Adequate Relief of Pain
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Milnacipran : Milnacipran, 100mg PO, BID, for six weeks
**ID:** OG000
**Title:** Group A (50mg - 100mg)
##### Group
**Description:** Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.

Milnacipran : Milnacipran, 50mg PO BID for 12 weeks
**ID:** OG001
**Title:** Group B (50mg x12)
##### Group
**Description:** Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.
**ID:** OG002
**Title:** Group C (Placebo - 50mg)
#### Outcome Measure 4
**Description:** Treatment Efficacy Questionnaire is a measure of treatment effectiveness. The score ranges from 1 to 48, 1 is minimum score and 48 is the maximum score. The investigators was looking to see if the Milnacipran treatment groups have a higher proportion of subjects with significant improvement in efficacy, judged as a TEQ score of \>28, compared to placebo group.
**Parameter Type:** NUMBER
**Population Description:** Only one subject was enrolled and was analyzed even though subject did not complete the study.
**Reporting Status:** POSTED
**Time Frame:** Twelve Weeks
**Title:** Treatment Efficacy Questionnaire (TEQ)
**Type:** SECONDARY
**Unit of Measure:** percentage of subject with score >28
##### Group
**Description:** Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Milnacipran : Milnacipran, 100mg PO, BID, for six weeks
**ID:** OG000
**Title:** Group A (50mg - 100mg)
##### Group
**Description:** Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.

Milnacipran : Milnacipran, 50mg PO BID for 12 weeks
**ID:** OG001
**Title:** Group B (50mg x12)
##### Group
**Description:** Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.
**ID:** OG002
**Title:** Group C (Placebo - 50mg)
#### Outcome Measure 5
**Description:** The investigator was looking to see if, for group A, when increased from 50 mg BID to 100 mg BID there is significant improvement of pain scores i.e. 30% pain reduction, and for group C, if there was significant improvement of pain scores when switched from placebo to 50 mg BID of Milnacipran
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 12 Weeks
**Title:** Dose Related Incremental Benefit in Pain Reduction Based on VAS
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Milnacipran : Milnacipran, 100mg PO, BID, for six weeks
**ID:** OG000
**Title:** Group A (50mg - 100mg)
##### Group
**Description:** Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.

Milnacipran : Milnacipran, 50mg PO BID for 12 weeks
**ID:** OG001
**Title:** Group B (50mg x12)
##### Group
**Description:** Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.
**ID:** OG002
**Title:** Group C (Placebo - 50mg)
### Participant Flow Module
#### Group
**Description:** Group A will begin treatment with Milnacipran 50mg twice a day (BID) (n=20) during Phase I and will be increased to 100mg BID during Phase II

Milnacipran : 50mg Milnacipran per orally (PO), BID, for 6 weeks.

Milnacipran : Milnacipran, 100mg PO, BID, for six weeks
**ID:** FG000
**Title:** Group A (50mg - 100mg)
#### Group
**Description:** Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.

Milnacipran : Milnacipran, 50mg PO BID for 12 weeks
**ID:** FG001
**Title:** Group B (50mg x12)
#### Group
**Description:** Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II

Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.

Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.
**ID:** FG002
**Title:** Group C (Placebo - 50mg)
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Study terminated
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
**Pre-Assignment Details:** Subjects undergo screening labs and questionnaires to make sure subjects are healthy and don't have any underlying conditions. Subjects who had clinically significant labs or Hospital Anxiety and depression scale(HADS)score more than 17 were excluded.
**Recruitment Details:** The subjects were recruited from community using University of North Carolina (UNC) mass email system, newspaper advertisement and UNC gastrointestinal (GI) clinic referral.
**Has Results:** True