Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)

Irritable Bowel Syndrome Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553591
• Other study ID #: 27018966IBS3001
• Secondary ID: 2012-001600-38
• Status: Completed
• Phase: Phase 3
• Start date: May 29, 2012
• Est. completion date: July 29, 2014

Study information

• Verified date: August 2018
• Source: Furiex Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1282
• Est. completion date: July 29, 2014
• Est. primary completion date: July 29, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.

2. Participant has had a colonoscopy performed:

• Within 10 years prior to Prescreening if participant is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or computed tomography (CT) colonography within the past 5 years is acceptable)

• Since the onset (if applicable) of any of the following alarm features for participants of any age:

• Participant has documented weight loss within the past 6 months

• Participant has nocturnal symptoms

• Participant has a familial history of first-degree relatives with colon cancer or

• Participant has blood mixed with their stool (excluding blood from hemorrhoids).

3. Female participants must be:

• Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,

• Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),

• Abstinent, or

• If sexually active, be practicing an effective method of birth control.

Exclusion Criteria:

1. Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.

2. Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.

3. Participant has a history of diverticulitis within 3 months prior to Prescreening.

4. Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).

5. Participant has any of the following surgical history:

• Cholecystectomy with any history of post cholecystectomy biliary tract pain

• Any abdominal surgery within the 3 months prior to Prescreening

• Participant has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)

Other protocol-specific eligibility criteria may apply.

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Eluxadoline
Oral tablets twice daily
• Placebo
Oral tablets twice daily

Locations

Country	Name	City	State
Canada	Furiex Research Site	Bridgewater	Nova Scotia
Canada	Furiex Research Site	Cambridge	Ontario
Canada	Furiex Research Site	Halifax	Nova Scotia
Canada	Furiex Research Site	Kamloops	British Columbia
Canada	Furiex Research Site	Kelowna	British Columbia
Canada	Furiex Research Site	London	Ontario
Canada	Furiex Research Site	Niagara Falls	Ontario
Canada	Furiex Research Site	Oshawa	Ontario
Canada	Furiex Research Site	Winnipeg	Manitoba
United Kingdom	Furiex Research Site	Bath
United Kingdom	Furiex Research Site	Bath
United Kingdom	Furiex Research Site	Blackpool	Lancashire
United Kingdom	Furiex Research Site	Burbage	Leicestershire
United Kingdom	Furiex Research Site	Chesterfield	Derbyshire
United Kingdom	Furiex Research Site	Chippenham	Wiltshire
United Kingdom	Furiex Research Site	Coventry
United Kingdom	Furiex Research Site	Dorking
United Kingdom	Furiex Research Site	Haxey
United Kingdom	Furiex Research Site	Leamington Spa	Warwickshire
United Kingdom	Furiex Research Site	London
United Kingdom	Furiex Research Site	Shrewsbury
United Kingdom	Furiex Research Site	Southampton
United Kingdom	Furiex Research Site	Strensall
United Kingdom	Furiex Research Site	Thornton
United Kingdom	Furiex Research Site	Thornton-Cleveleys	Lancashire
United Kingdom	Furiex Research Site	Torpoint
United States	Furiex Research Site	Addison	Illinois
United States	Furiex Research Site	Albuquerque	New Mexico
United States	Furiex Research Site	Anderson	South Carolina
United States	Furiex Research Site	Ann Arbor	Michigan
United States	Furiex Research Site	Annapolis	Maryland
United States	Furiex Research Site	Asheville	North Carolina
United States	Furiex Research Site	Asheville	North Carolina
United States	Furiex Research Site	Athens	Alabama
United States	Furiex Research Site	Atlanta	Georgia
United States	Furiex Research Site	Austin	Texas
United States	Furiex Research Site	Austin	Texas
United States	Furiex Research Site	Azusa	California
United States	Furiex Research Site	Baker	Louisiana
United States	Furiex Research Site	Bangor	Maine
United States	Furiex Research Site	Baytown	Texas
United States	Furiex Research Site	Beaumont	Texas
United States	Furiex Research Site	Beavercreek	Ohio
United States	Furiex Research Site	Bell Gardens	California
United States	Furiex Research Site	Belle Vernon	Pennsylvania
United States	Furiex Research Site	Bellevue	Nebraska
United States	Furiex Research Site	Berea	Ohio
United States	Furiex Research Site	Beverly Hills	California
United States	Furiex Research Site	Billings	Montana
United States	Furiex Research Site	Birmingham	Alabama
United States	Furiex Research Site	Blue Ridge	Georgia
United States	Furiex Research Site	Boca Raton	Florida
United States	Furiex Research Site	Brandon	Florida
United States	Furiex Research Site	Bristol	Tennessee
United States	Furiex Research Site	Brockton	Massachusetts
United States	Furiex Research Site	Brooklyn	New York
United States	Furiex Research Site	Brownsburg	Indiana
United States	Furiex Research Site	Carson	California
United States	Furiex Research Site	Centerville	Ohio
United States	Furiex Research Site	Chandler	Arizona
United States	Furiex Research Site	Charleston	South Carolina
United States	Furiex Research Site	Charlotte	North Carolina
United States	Furiex Research Site	Chaska	Minnesota
United States	Furiex Research Site	Chattanooga	Tennessee
United States	Furiex Research Site	Chevy Chase	Maryland
United States	Furiex Research Site	Chicago	Illinois
United States	Furiex Research Site	Chula Vista	California
United States	Furiex Research Site	Cincinnati	Ohio
United States	Furiex Research Site	Cincinnati	Ohio
United States	Furiex Research Site	Clarksville	Tennessee
United States	Furiex Research Site	Clearwater	Florida
United States	Furiex Research Site	Clinton	Utah
United States	Furiex Research Site	Clive	Iowa
United States	Furiex Research Site	Collingswood	New Jersey
United States	Furiex Research Site	Colorado Springs	Colorado
United States	Furiex Research Site	Colorado Springs	Colorado
United States	Furiex Research Site	Columbia	Tennessee
United States	Furiex Research Site	Columbus	Ohio
United States	Furiex Research Site	Cooper City	Florida
United States	Furiex Research Site	Coral Springs	Florida
United States	Furiex Research Site	Corona	California
United States	Furiex Research Site	Covington	Louisiana
United States	Furiex Research Site	Crestview Hills	Kentucky
United States	Furiex Research Site	Crystal River	Florida
United States	Furiex Research Site	Cumberland	Rhode Island
United States	Furiex Research Site	Dallas	Texas
United States	Furiex Research Site	Davenport	Iowa
United States	Furiex Research Site	Dayton	Ohio
United States	Furiex Research Site	Dayton	Ohio
United States	Furiex Research Site	Doral	Florida
United States	Furiex Research Site	Draper	Utah
United States	Furiex Research Site	Durham	North Carolina
United States	Furiex Research Site	Eagle	Idaho
United States	Furiex Research Site	East Providence	Rhode Island
United States	Furiex Research Site	Edison	New Jersey
United States	Furiex Research Site	El Cajon	California
United States	Furiex Research Site	El Paso	Texas
United States	Furiex Research Site	Encino	California
United States	Furiex Research Site	Endwell	New York
United States	Furiex Research Site	Englewood	Ohio
United States	Furiex Research Site	Eustis	Florida
United States	Furiex Research Site	Evansville	Indiana
United States	Furiex Research Site	Fargo	North Dakota
United States	Furiex Research Site	Fargo	North Dakota
United States	Furiex Research Site	Fayetteville	North Carolina
United States	Furiex Research Site	Foley	Alabama
United States	Furiex Research Site	Fort Mill	South Carolina
United States	Furiex Research Site	Franklin	Tennessee
United States	Furiex Research Site	Franklin	Ohio
United States	Furiex Research Site	Garden Grove	California
United States	Furiex Research Site	Glendale	Arizona
United States	Furiex Research Site	Great Neck	New York
United States	Furiex Research Site	Greensboro	North Carolina
United States	Furiex Research Site	Greenville	South Carolina
United States	Furiex Research Site	Greer	South Carolina
United States	Furiex Research Site	Greer	South Carolina
United States	Furiex Research Site	Hammond	Louisiana
United States	Furiex Research Site	Hartsdale	New York
United States	Furiex Research Site	Hawesville	Kentucky
United States	Furiex Research Site	Hialeah	Florida
United States	Furix Research Site	Hialeah	Florida
United States	Furiex Research Site	Hickory	North Carolina
United States	Furiex Research Site	High Point	North Carolina
United States	Furiex Research Site	Houston	Texas
United States	Furiex Research Site	Houston	Texas
United States	Furiex Research Site	Houston	Texas
United States	Furiex Research Site	Houston	Texas
United States	Furiex Research Site	Huntsville	Alabama
United States	Furiex Research Site	Indianapolis	Indiana
United States	Furiex Research Site	Inverness	Florida
United States	Furiex Research Site	Iowa City	Iowa
United States	Furiex Research Site	Jackson	Mississippi
United States	Furiex Research Site	Jacksonville	Florida
United States	Furiex Research Site	Jefferson City	Missouri
United States	Furiex Research Site	Jenkintown	Pennsylvania
United States	Furiex Research Site	Johns Creek	Georgia
United States	Furiex Research Site	Johnson City	Tennessee
United States	Furiex Research Site	Johnstown	Pennsylvania
United States	Furiex Research Site	Kew Gardens	New York
United States	Furiex Research Site	Kinston	North Carolina
United States	Furiex Research Site	Kissimmee	Florida
United States	Furiex Research Site	Lafayette	Colorado
United States	Furiex Research Site	Lakewood	Colorado
United States	Furiex Research Site	Lansdale	Pennsylvania
United States	Furiex Research Site	Las Vegas	Nevada
United States	Furiex Research Site	Las Vegas	Nevada
United States	Furiex Research Site	Lenoir	North Carolina
United States	Furiex Research Site	Lexington	Kentucky
United States	Furiex Research Site	Lexington	Kentucky
United States	Furiex Research Site	Lilburn	Georgia
United States	Furiex Research Site	Little Rock	Arkansas
United States	Furiex Research Site	Little Rock	Arkansas
United States	Furiex Research Site	Logan	Utah
United States	Furiex Research Site	Lomita	California
United States	Furiex Research Site	Longmont	Colorado
United States	Furiex Research Site	Los Angeles	California
United States	Furiex Research Site	Louisville	Kentucky
United States	Furiex Research Site	Lynchburg	Virginia
United States	Furiex Research Site	Madisonville	Kentucky
United States	Furiex Research Site	Maitland	Florida
United States	Furiex Research Site	Marion	Ohio
United States	Furiex Research Site	Marshall	Texas
United States	Furiex Research Site	Melbourne	Florida
United States	Furiex Research Site	Memphis	Tennessee
United States	Furiex Research Site	Mesa	Arizona
United States	Furiex Research Site	Metairie	Louisiana
United States	Furiex Research Site	Miami	Florida
United States	Furiex Research Site	Miami	Florida
United States	Furiex Research Site	Miami	Florida
United States	Furiex Research Site	Miami	Florida
United States	Furiex Research Site	Miami	Florida
United States	Furiex Research Site	Miami	Florida
United States	Furiex Research Site	Miami	Florida
United States	Furiex Research Site	Miami	Florida
United States	Furiex Research Site	Miami Springs	Florida
United States	Furiex Research Site	Miamisburg	Ohio
United States	Furiex Research Site	Middleburg Heights	Ohio
United States	Furiex Research Site	Miramar	Florida
United States	Furiex Research Site	Monterey Park	California
United States	Furiex Research Site	Morgantown	West Virginia
United States	Furiex Research Site	Morton	Illinois
United States	Furiex Research Site	Murrieta	California
United States	Furiex Research Site	Myrtle Beach	South Carolina
United States	Furiex Research Site	Myrtle Beach	South Carolina
United States	Furiex Research Site	Naples	Florida
United States	Furiex Research Site	New Orleans	Louisiana
United States	Furiex Research Site	New Port Richey	Florida
United States	Furiex Research Site	New Smyrna Beach	Florida
United States	Furiex Research Site	New Windsor	New York
United States	Furiex Research Site	New York	New York
United States	Furiex Research Site	Newport Beach	California
United States	Furiex Research Site	Newton	Kansas
United States	Furiex Research Site	North Hollywood	California
United States	Furiex Research Site	North Little Rock	Arkansas
United States	Furiex Research Site	North Massapequa	New York
United States	Furiex Research Site	Norwalk	Connecticut
United States	Furiex Research Site	Oakland	California
United States	Furiex Research Site	Oakwood	Georgia
United States	Furiex Research Site	Ogden	Utah
United States	Furiex Research Site	Omaha	Nebraska
United States	Furiex Research Site	Omaha	Nebraska
United States	Furiex Research Site	Opelousas	Louisiana
United States	Furiex Research Site	Orlando	Florida
United States	Furiex Research Site	Orlando	Florida
United States	Furiex Research Site	Orlando	Florida
United States	Furiex Research Site	Ormond Beach	Florida
United States	Furiex Research Site	Oviedo	Florida
United States	Furiex Research Site	Owensboro	Kentucky
United States	Furiex Research Site	Oxnard	California
United States	Furiex Research Site	Ozark	Alabama
United States	Furiex Research Site	Palm Beach	Florida
United States	Furiex Research Site	Perry	Georgia
United States	Furiex Research Site	Philadelphia	Pennsylvania
United States	Furiex Research Site	Philadelphia	Pennsylvania
United States	Furiex Research Site	Phoenix	Arizona
United States	Furiex Research Site	Pinellas Park	Florida
United States	Furiex Research Site	Pinellas Park	Florida
United States	Furiex Research Site	Pismo Beach	California
United States	Furiex Research Site	Pittsburgh	Pennsylvania
United States	Furiex Research Site	Pittsburgh	Pennsylvania
United States	Furiex Research Site	Plano	Texas
United States	Furiex Research Site	Port Orange	Florida
United States	Furiex Research Site	Poughkeepsie	New York
United States	Furiex Research Site	Poway	California
United States	Furiex Research Site	Prairie Village	Kansas
United States	Furiex Research Site	Raleigh	North Carolina
United States	Furiex Research Site	Raleigh	North Carolina
United States	Furiex Research Site	Richmond	Virginia
United States	Furiex Research Site	Ridgefield	Connecticut
United States	Furiex Research Site	Riverside	California
United States	Furiex Research Site	Roseville	California
United States	Furiex Research Site	Sacramento	California
United States	Furiex Research Site	Saint Louis	Missouri
United States	Furiex Research Site	Saint Louis	Missouri
United States	Furiex Research Site	Saint Peters	Missouri
United States	Furiex Research Site	Salisbury	North Carolina
United States	Furiex Research Site	Salt Lake City	Utah
United States	Furiex Research Site	San Antonio	Texas
United States	Furiex Research Site	San Antonio	Texas
United States	Furiex Research Site	San Antonio	Texas
United States	Furiex Research Site	San Diego	California
United States	Furiex Research Site	San Diego	California
United States	Furiex Research Site	Sanford	Florida
United States	Furiex Research Site	Santa Monica	California
United States	Furiex Research Site	Sebastian	Florida
United States	Furiex Research Site	Shawnee Mission	Kansas
United States	Furiex Research Site	Shreveport	Louisiana
United States	Furiex Research Site	Shreveport	Louisiana
United States	Furiex Research Site	Simpsonville	South Carolina
United States	Furiex Research Site	Smyrna	Tennessee
United States	Furiex Research Site	Snellville	Georgia
United States	Furiex Research Site	South Miami	Florida
United States	Furiex Research Site	Southfield	Michigan
United States	Furiex Research Site	Spokane	Washington
United States	Furiex Research Site	Spokane	Washington
United States	Furiex Research Site	Spokane	Washington
United States	Furiex Research Site	Stevensville	Michigan
United States	Furiex Research Site	Sugar Land	Texas
United States	Furiex Research Site	Summerville	South Carolina
United States	Furiex Research Site	Tampa	Florida
United States	Furiex Research Site	Tampa	Florida
United States	Furiex Research Site	Thousand Oaks	California
United States	Furiex Research Site	Tucson	Arizona
United States	Furiex Research Site	Tulsa	Oklahoma
United States	Furiex Research Site	Tulsa	Oklahoma
United States	Furiex Research Site	Tulsa	Oklahoma
United States	Furiex Research Site	Uniontown	Pennsylvania
United States	Furiex Research Site	Upper Saint Clair	Pennsylvania
United States	Furiex Research Site	Venice	Florida
United States	Furiex Research Site	Wadsworth	Ohio
United States	Furiex Research Site	Watertown	Massachusetts
United States	Furiex Research Site	Wauwatosa	Wisconsin
United States	Furiex Research Site	Wellington	Florida
United States	Furiex Research Site	Wenatchee	Washington
United States	Furiex Research Site	West Des Moines	Iowa
United States	Furiex Research Site	West Jordan	Utah
United States	Furiex Research Site	Wichita	Kansas
United States	Furiex Research Site	Wichita	Kansas
United States	Furiex Research Site	Williamsburg	Virginia
United States	Furiex Research Site	Winston-Salem	North Carolina
United States	Furiex Research Site	Winter Haven	Florida
United States	Furiex Research Site	Winter Park	Florida
United States	Furiex Research Site	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Furiex Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores	Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by =30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by =30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.	Up to 12 Weeks
Secondary	Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores	Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by =30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by =30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.	Up to 26 Weeks
Secondary	Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals	Pain responders were defined as participants who met the daily pain response criteria (ie, the worst abdominal pain score in the past 24 hours improved by =30% compared to baseline) for at least 50% of days with diary entries during each interval. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.	12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
Secondary	Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals	Stool consistency responders: participants who met daily stool consistency response criterion (ie,score of 1, 2, 3, or 4 or absence of bowel movement if accompanied by =30% improvement in worst abdominal pain compared to baseline pain) for at least 50% of days with diary entries during each interval. BSS was defined as 7-point Scale in which score of 1= separate hard lumps, 2= sausage shaped but lumpy, 3= sausage-like with cracks on the surface, 4= sausage-like but smooth and soft, 5= soft blobs with clear cut edges, 6= fluffy pieces with ragged edges, and 7= watery with no solid pieces. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over 12-week interval, and a minimum of 110 days of diary entries over 26-week interval to be a responder.	12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
Secondary	Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals	IBS-d global symptom responders were defined as those participants who met the daily IBS-d global symptom response criteria (ie, IBS-d global symptom score of 0 [none] or 1 [mild]; or a daily IBS-d global symptom score improved by =2.0 compared to the baseline average) for at least 50% of days with diary entries during each interval. IBS-d Global Symptom Scale was a 5 point scale, score ranging from 0 to 4. 0= no symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms and 4 = very severe symptoms. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.	12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
Secondary	Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale	IBS-QoL responders were defined as participants who achieved at least a 14-point improvement in IBS-QoL total score from baseline to the applicable visit. The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100-point (0= worst; 100=better) scale for ease of interpretation.	Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (End of Treatment [EOT])
Secondary	Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale	Adequate relief of IBS symptoms was assessed once weekly by participants answering the IBS-AR item in the electronic diary. IBS-AR responders were defined as participants with a weekly response of "Yes" to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval. A participant must have had a positive response on =6 weeks for the 12-week interval and =13 weeks for the 26-week interval, regardless of diary compliance, to be a responder.	12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)
Secondary	Change From Baseline in Daily Abdominal Discomfort Scores	Symptoms of abdominal discomfort were recorded on a 0 to 10 scale, where 0 corresponded to no discomfort and 10 corresponded to worst imaginable discomfort. A negative change from Baseline indicates the discomfort decreased.	Baseline, Weeks 4, 12 and 26
Secondary	Change From Baseline in Daily Abdominal Bloating Scores	Symptoms of abdominal bloating were recorded on a 0 to 10 scale, where 0 corresponded to no bloating and 10 corresponded to worst imaginable bloating. A negative change from Baseline indicates the bloating decreased.	Baseline, Weeks 4, 12 and 26
Secondary	Number of Bowel Movements Per Day	Participants recorded the number of bowel movements over 24 hours daily throughout the treatment.	Weeks 4, 12 and 26
Secondary	Number of Bowel Incontinence Episodes	Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment.	Weeks 4, 12 and 26
Secondary	Number of Bowel Incontinence Free Days	An incontinence free day was one where the participant reports zero incontinence episodes. The number of incontinence free days for a participant was assessed each week based on the number of reported days.	Weeks 4, 12 and 26
Secondary	Number of Urgency Episodes Per Day	Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment.	Weeks 4, 12 and 26
Secondary	IBS-QoL Total Scores	The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation.	Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (EOT)
Secondary	Change From Baseline in IBS-QoL Total Scores	The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. A positive change from Baseline indicates that quality of life improved.	Baseline, Weeks 4, 8, 12, 18, 26, 36, 44, and 52/EOT