## Protocol Section
### Identification Module
**NCT ID:** NCT01554579

**Brief Title:** A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee

#### Organization Study ID Info
**ID:** 7264-004
#### Organization
**Class:** INDUSTRY
**Full Name:** Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
#### Secondary ID Infos
**Domain:** Afferent Pharmaceuticals
**ID:** AF219004
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2013-11-21

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-06-27

**Type:** ACTUAL

**Last Update Submit Date:** 2019-06-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-11-11

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-03-01

**Type:** ACTUAL

**Results First Submit Date:** 2016-09-23

**Results First Submit QC Date:** 2017-01-10

#### Start Date
**Date:** 2012-03-29

**Type:** ACTUAL

**Status Verified Date:** 2019-06

#### Study First Post Date
**Date:** 2012-03-15
**Type:** ESTIMATED
**Study First Submit Date:** 2012-03-12
**Study First Submit QC Date:** 2012-03-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to assess the efficacy of a single dose level of gefapixant (AF-219/MK-7264) in subjects with moderate to severe pain associated with osteoarthritis (OA) of the knee compared with placebo after 4 weeks of treatment.

The study will also assess the safety and tolerability, changes in physical function, stiffness, treatment response and health outcomes.

**Detailed Description:** Subjects who satisfy entry criteria at Screening will enter the Washout Phase, discontinuing their current nonsteroidal anti-inflammatory drug (NSAID) therapy.

Up to 220 subjects who fulfill flare (and other entry) criteria will be randomized to gefapixant or placebo.

Subjects will complete Treatment Visits 1, 2, 3, and 4 weeks after starting study drug. At each Treatment Visit, subjects will undergo efficacy assessments and safety procedures. During the Washout and Treatment Phases subjects will complete the 'average pain' Numeric Pain Rating Scale (NPRS) and count of rescue medication used for the preceding 24 hours.

Subjects will return 2 weeks after their last Treatment Visit (for a Follow-Up Visit).

### Conditions Module

**Conditions:**

- Osteoarthritis of the Knee

### 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:** 171

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Sugar Pill

**Label:** Sugar pill

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: Gefapixant

**Label:** Gefapixant

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Gefapixant

**Description:** BID

**Name:** Gefapixant

**Other Names:**

- AF-219

- MK-7264

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Sugar pill

**Description:** Placebo

**Name:** Sugar Pill

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Subjects were instructed to select a number on a scale that best described their knee arthritis pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst possible pain. The scale was completed by telephone (an interactive voice response system \[IVRS\]) every evening before bedtime.

**Measure:** The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)

**Time Frame:** 2 Weeks

#### Secondary Outcomes

**Description:** This is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). This is a questionnaire that asks subjects to evaluate their pain, stiffness, and physical activities affecting their knee over the past 48 hours. Subjects evaluate their pain, stiffness and physical activities by selecting a number between 0 and 10 where 0 is no pain/no stiffness/no difficulty doing physical activities and 10 is extreme pain/extreme stiffness/extreme difficulty doing physical activities. The questionnaire was administered at Screening, Baseline and at the end of Week 4 by telephone (an interactive voice response system \[IVRS\]) before bedtime. The scores for each category are totaled (range is 0-100). A lower total score means less pain and a higher total score means greater pain.

**Measure:** WOMAC Scores

**Time Frame:** 4 Weeks

**Description:** The SF-36 (acute version 2) was a 36 question survey administered at Baseline and at the end of study or early termination (Week 4). The questionnaire contained numerous domain scores to evaluate physical function, mental function, general health, bodily pain, social functioning and vitality. The question of interest for the analysis was question #1 regarding walking pain. Scores range from 0 - 100. A lower score means decreased pain while walking and a higher score means increased pain while walking.

**Measure:** SF-36

**Time Frame:** 4 Weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Men or women
* Women of child bearing potential must not be pregnant during the study and must use two forms of birth control
* Men and their female partners must use two forms of birth control
* Clinical and radiographic evidence of chronic knee osteoarthritis
* An average NPRS score of \>=5 and \<=9 over a 4-7 day washout period of their previous osteoarthritis medications
* Ambulatory
* Have provided written informed consent

**Maximum Age:** 80 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Phoenix

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Arizona

**Zip:** 85018

**Location 2:**

**City:** Phoenix

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Arizona

**Zip:** 85027

**Location 3:**

**City:** San Diego

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** California

**Zip:** 92108

**Location 4:**

**City:** Clearwater

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Florida

**Zip:** 33756

**Location 5:**

**City:** Orlando

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Florida

**Zip:** 32806

**Location 6:**

**City:** Pinellas Park

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Florida

**Zip:** 33781

**Location 7:**

**City:** Atlanta

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Georgia

**Zip:** 30329

**Location 8:**

**City:** Wichita

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Kansas

**Zip:** 67203

**Location 9:**

**City:** New Bedford

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Massachusetts

**Zip:** 02740

**Location 10:**

**City:** Watertown

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Massachusetts

**Zip:** 02472

**Location 11:**

**City:** Troy

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Michigan

**Zip:** 48098

**Location 12:**

**City:** Olive Branch

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Mississippi

**Zip:** 38654

**Location 13:**

**City:** Hazelwood

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Missouri

**Zip:** 63042

**Location 14:**

**City:** Saint Louis

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Missouri

**Zip:** 63141

**Location 15:**

**City:** Albuquerque

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** New Mexico

**Zip:** 87102

**Location 16:**

**City:** Asheville

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** North Carolina

**Zip:** 28803

**Location 17:**

**City:** Greensboro

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** North Carolina

**Zip:** 27408

**Location 18:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** North Carolina

**Zip:** 27103

**Location 19:**

**City:** Cincinnati

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Ohio

**Zip:** 45219

**Location 20:**

**City:** Toledo

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Ohio

**Zip:** 43623

**Location 21:**

**City:** Medford

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Oregon

**Zip:** 97504

**Location 22:**

**City:** Duncansville

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Pennsylvania

**Zip:** 16635

**Location 23:**

**City:** Warwick

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Rhode Island

**Zip:** 02886

**Location 24:**

**City:** Greer

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** South Carolina

**Zip:** 29650

**Location 25:**

**City:** Mount Pleasant

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** South Carolina

**Zip:** 29464

**Location 26:**

**City:** Austin

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Texas

**Zip:** 78705

**Location 27:**

**City:** Dallas

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Texas

**Zip:** 75231

**Location 28:**

**City:** Houston

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Texas

**Zip:** 77062

**Location 29:**

**City:** San Antonio

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Texas

**Zip:** 78209

**Location 30:**

**City:** San Antonio

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Texas

**Zip:** 78229

**Location 31:**

**City:** Clinton

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Utah

**Zip:** 84015

**Location 32:**

**City:** Roanoke

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Virginia

**Zip:** 24018

**Location 33:**

**City:** Renton

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Washington

**Zip:** 98057

**Location 34:**

**City:** Kenosha

**Country:** United States

**Facility:** Afferent Investigative Site

**State:** Wisconsin

**Zip:** 53142

### IPD Sharing Statement Module

**Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

**IPD Sharing:** YES

**URL:** http://engagezone.msd.com/ds_documentation.php

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: HIGH

- As Found: Osteoarthritis of the Knee

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

- ID: D000020370

- Term: Osteoarthritis, Knee

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Sugar Pill

**Description:** Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.

**ID:** EG000

**Other Num Affected:** 17

**Other Num at Risk:** 86

**Serious Number Affected:** 1

**Serious Number At Risk:** 86

**Title:** Sugar Pill

**Group ID:** EG001

**Title:** Gefapixant

**Description:** Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.

**ID:** EG001

**Other Num Affected:** 75

**Other Num at Risk:** 85

**Serious Number At Risk:** 85

**Title:** Gefapixant

**Frequency Threshold:** 5

#### Other Events

**Term:** Dysgeusia

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Ageusia

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** headache

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** hypogeusia

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** dizziness

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Bronchitis

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 86

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 85

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 86

**Group ID:** BG001

**Value:** 85

**Group ID:** BG002

**Value:** 171

**Units:** Participants

### Group

**ID:** BG000

**Title:** Sugar Pill

**Description:** Sugar Pill: Placebo

### Group

**ID:** BG001

**Title:** Gefapixant

**Description:** Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.

### Group

**ID:** BG002

**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

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 64

#### Measurement

**Group ID:** BG001

**Value:** 65

#### Measurement

**Group ID:** BG002

**Value:** 129

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

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 42

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 52

#### Measurement

**Group ID:** BG001

**Value:** 57

#### Measurement

**Group ID:** BG002

**Value:** 109

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 34

#### Measurement

**Group ID:** BG001

**Value:** 28

#### Measurement

**Group ID:** BG002

**Value:** 62

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 21

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 41

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 62

#### Measurement

**Group ID:** BG001

**Value:** 62

#### Measurement

**Group ID:** BG002

**Value:** 124

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 86

#### Measurement

**Group ID:** BG001

**Value:** 85

#### Measurement

**Group ID:** BG002

**Value:** 171

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 5

**Upper Limit:** 9

**Value:** 6.7

#### Measurement

**Group ID:** BG001

**Lower Limit:** 5

**Upper Limit:** 9

**Value:** 6.8

#### Measurement

**Group ID:** BG002

**Lower Limit:** 5

**Upper Limit:** 9

**Value:** 6.75

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Description:** Subjects were instructed to select a number between 0 and 10 where 0 is no pain and 10 is the worst possible pain. The scale was completed by telephone (an interactive voice response system \[IVRS\]) every evening before bedtime.
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Numeric Pain Rating Scale (NPRS)
**Unit of Measure:** units on a scale
## Results Section - More Information Module
### Certain Agreement
**Other Details:** 60 days prior to the submission of any results, the PI shall submit to SPONSOR any proposed PUBLICATION, which period may be extended for an additional 30 days if requested by SPONSOR. If any Confidential Information should be redacted or patent applications relating to an Invention should be filed prior to PUBLICATION, then PUBLICATION will be delayed until patent application has been filed. Delay of a PUBLICATION shall not exceed 24 months from the date of such notice to the PI.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** info@afferentpharma.com
**Organization:** Afferent Pharmaceuticals
**Phone:** 650-286-1276
**Title:** Clinical Development
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 10
- **Value:** 5.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 10
- **Value:** 4.9
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 23.12
- **Upper Limit:** 
- **Value:** 40.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 25.26
- **Upper Limit:** 
- **Value:** 41.0
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.39
- **Upper Limit:** 
- **Value:** 3.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.77
- **Upper Limit:** 
- **Value:** 4.1
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Subjects were instructed to select a number on a scale that best described their knee arthritis pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst possible pain. The scale was completed by telephone (an interactive voice response system \[IVRS\]) every evening before bedtime.
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Population Description:** Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.
**Reporting Status:** POSTED
**Time Frame:** 2 Weeks
**Title:** The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
**ID:** OG000
**Title:** Sugar Pill
##### Group
**Description:** Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
**ID:** OG001
**Title:** Gefapixant
#### Outcome Measure 2
**Description:** This is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). This is a questionnaire that asks subjects to evaluate their pain, stiffness, and physical activities affecting their knee over the past 48 hours. Subjects evaluate their pain, stiffness and physical activities by selecting a number between 0 and 10 where 0 is no pain/no stiffness/no difficulty doing physical activities and 10 is extreme pain/extreme stiffness/extreme difficulty doing physical activities. The questionnaire was administered at Screening, Baseline and at the end of Week 4 by telephone (an interactive voice response system \[IVRS\]) before bedtime. The scores for each category are totaled (range is 0-100). A lower total score means less pain and a higher total score means greater pain.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.
**Reporting Status:** POSTED
**Time Frame:** 4 Weeks
**Title:** WOMAC Scores
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Sugar Pill: Placebo
**ID:** OG000
**Title:** Sugar Pill
##### Group
**Description:** Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
**ID:** OG001
**Title:** Gefapixant
#### Outcome Measure 3
**Description:** The SF-36 (acute version 2) was a 36 question survey administered at Baseline and at the end of study or early termination (Week 4). The questionnaire contained numerous domain scores to evaluate physical function, mental function, general health, bodily pain, social functioning and vitality. The question of interest for the analysis was question #1 regarding walking pain. Scores range from 0 - 100. A lower score means decreased pain while walking and a higher score means increased pain while walking.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.
**Reporting Status:** POSTED
**Time Frame:** 4 Weeks
**Title:** SF-36
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Sugar Pill: Placebo
**ID:** OG000
**Title:** Sugar Pill
##### Group
**Description:** Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
**ID:** OG001
**Title:** Gefapixant
### Participant Flow Module
#### Group
**Description:** Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
**ID:** FG000
**Title:** Sugar Pill
#### Group
**Description:** Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
**ID:** FG001
**Title:** Gefapixant
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 6
###### Reason
**Group ID:** FG001
**Number of Subjects:** 25
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 86
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 85
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 76
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 58
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 27
**Has Results:** True