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: NCT01553747
• Other study ID #: 27018966IBS3002
• Secondary ID: 2012-001601-24
• Status: Completed
• Phase: Phase 3
• Start date: May 29, 2012
• Est. completion date: January 9, 2014

Study information

• Verified date: July 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: 1146
• Est. completion date: January 9, 2014
• Est. primary completion date: January 9, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Participant is 18 to 80 years old

2. 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

• 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	Burlington	Ontario
Canada	Furiex Research Site	Hawkesbury	Ontario
Canada	Furiex Research Site	Kelowna	British Columbia
Canada	Furiex Research Site	London	Ontario
Canada	Furiex Research Site	Newmarket	Ontario
Canada	Furiex Research Site	Sarnia	Ontario
Canada	Furiex Research Site	St. John's	Newfoundland and Labrador
Canada	Furiex Research Site	Sudbury	Ontario
Canada	Furiex Research Site	Toronto	Ontario
Canada	Furiex Research Site	Vaughan	Ontario
Puerto Rico	Furiex Research Site	San Juan
United Kingdom	Furiex Research Site	Birmingham
United Kingdom	Furiex Research Site	Blackpool	Lancashire
United Kingdom	Furiex Research Site	Chestfield	Kent
United Kingdom	Furiex Research Site	County Durham
United Kingdom	Furiex Research Site	Coventry
United Kingdom	Furiex Research Site	Durham
United Kingdom	Furiex Research Site	Edinburgh
United Kingdom	Furiex Research Site	Manchester
United Kingdom	Furiex Research Site	Sheffield
United Kingdom	Furiex Research Site	Wigan
United States	Furiex Research Site	Addison	Illinois
United States	Furiex Research Site	Akron	Ohio
United States	Furiex Research Site	Albuquerque	New Mexico
United States	Furiex Research Site	Albuquerque	New Mexico
United States	Furiex Research Site	Albuquerque	New Mexico
United States	Furiex Research Site	Alexandria	Virginia
United States	Furiex Research Site	Alpharetta	Georgia
United States	Furiex Research Site	Anaheim	California
United States	Furiex Research Site	Anderson	South Carolina
United States	Furiex Research Site	Ann Arbor	Michigan
United States	Furiex Research Site	Athens	Georgia
United States	Furiex Research Site	Athens	Tennessee
United States	Furiex Research Site	Atlanta	Georgia
United States	Furiex Research Site	Atlanta	Georgia
United States	Furiex Research Site	Austin	Texas
United States	Furiex Research Site	Bay City	Michigan
United States	Furiex Research Site	Beaumont	Texas
United States	Furiex Research Site	Beavercreek	Ohio
United States	Furiex Research Site	Bedford	Texas
United States	Furiex Research Site	Bellevue	Nebraska
United States	Furiex Research Site	Billings	Montana
United States	Furiex Research Site	Biloxi	Mississippi
United States	Furiex Research Site	Birmingham	Alabama
United States	Furiex Research Site	Birmingham	Alabama
United States	Furiex Research Site	Blackwood	New Jersey
United States	Furiex Research Site	Boca Raton	Florida
United States	Furiex Research Site	Boise	Idaho
United States	Furiex Research Site	Boston	Massachusetts
United States	Furiex Research Site	Boston	Massachusetts
United States	Furiex Research Site	Bountiful	Utah
United States	Furiex Research Site	Boynton Beach	Florida
United States	Furiex Research Site	Bradenton	Florida
United States	Furiex Research Site	Brockton	Massachusetts
United States	Furiex Research Site	Brooksville	Florida
United States	Furiex Research Site	Brownsburg	Indiana
United States	Furiex Research Site	Burlington	Vermont
United States	Furiex Research Site	Cadillac	Michigan
United States	Furiex Research Site	Carnegie	Pennsylvania
United States	Furiex Research Site	Chapel Hill	North Carolina
United States	Furiex Research Site	Charleston	West Virginia
United States	Furiex Research Site	Chattanooga	Tennessee
United States	Furiex Research Site	Chicago	Illinois
United States	Furiex Research Site	Chicago	Illinois
United States	Furiex Research Site	Christiansburg	Virginia
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	Cincinnati	Ohio
United States	Furiex Research Site	Cincinnati	Ohio
United States	Furiex Research Site	Clearwater	Florida
United States	Furiex Research Site	Cleveland	Ohio
United States	Furiex Research Site	Clive	Iowa
United States	Furiex Research Site	Columbia	South Carolina
United States	Furiex Research Site	Columbia	South Carolina
United States	Furiex Research Site	Columbia	South Carolina
United States	Furiex Research Site	Columbia	Tennessee
United States	Furiex Research Site	Columbus	Ohio
United States	Furiex Research Site	Columbus	Ohio
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	Corsicana	Texas
United States	Furiex Research Site	Dallas	Texas
United States	Furiex Research Site	Dallas	Texas
United States	Furiex Research Site	Dayton	Ohio
United States	Furiex Research Site	Dayton	Ohio
United States	Furiex Research Site	Decatur	Alabama
United States	Furiex Research Site	Denver	Colorado
United States	Furiex Research Site	Denver	Colorado
United States	Furiex Research Site	Dunn	North Carolina
United States	Furiex Research Site	Dunwoody	Georgia
United States	Furiex Research Site	Eagle	Idaho
United States	Furiex Research Site	Easley	South Carolina
United States	Furiex Research Site	Edison	New Jersey
United States	Furiex Research Site	Elizabeth	New Jersey
United States	Furiex Research Site	Elkhorn	Nebraska
United States	Furiex Research Site	Encinitas	California
United States	Furiex Research Site	Eustis	Florida
United States	Furiex Research Site	Evansville	Indiana
United States	Furiex Research Site	Evergreen Park	Illinois
United States	Furiex Research Site	Flushing	New York
United States	Furiex Research Site	Fort Lauderdale	Florida
United States	Furiex Research Site	Fort Worth	Texas
United States	Furiex Research Site	Frisco	Texas
United States	Furiex Research Site	Garden Grove	California
United States	Furiex Research Site	Glendale	Arizona
United States	Furiex Research Site	Glendale	Arizona
United States	Furiex Research Site	Grand Rapids	Michigan
United States	Furiex Research Site	Granger	Indiana
United States	Furiex Research Site	Greensboro	North Carolina
United States	Furiex Research Site	Groveport	Ohio
United States	Furiex Research Site	Hagerstown	Maryland
United States	Furiex Research Site	Hallandale Beach	Florida
United States	Furiex Research Site	Hammond	Illinois
United States	Furiex Research Site	Hazelwood	Missouri
United States	Furiex Research Site	Hialeah	Florida
United States	Furiex Research Site	Hollis	New York
United States	Furiex Research Site	Hollywood	Maryland
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	Humble	Texas
United States	Furiex Research Site	Huntersville	North Carolina
United States	Furiex Research Site	Huntington Beach	California
United States	Furiex Research Site	Huntsville	Alabama
United States	Furiex Research Site	Hurst	Texas
United States	Furiex Research Site	Idaho Falls	Idaho
United States	Furiex Research Site	Irvine	California
United States	Furiex Research Site	Jackson	Tennessee
United States	Furiex Research Site	Jacksonville	Florida
United States	Furiex Research Site	Jonesboro	Arkansas
United States	Furiex Research Site	Jupiter	Florida
United States	Furiex Research Site	Kalamazoo	Michigan
United States	Furiex Research Site	Kettering	Ohio
United States	Furiex Research Site	Kinston	North Carolina
United States	Furiex Research Site	Knoxville	Tennessee
United States	Furiex Research Site	La Mesa	California
United States	Furiex Research Site	La Mirada	California
United States	Furiex Research Site	Laguna Hills	California
United States	Furiex Research Site	Lake Charles	Louisiana
United States	Furiex Research Site	Lakewood	California
United States	Furiex Research Site	Las Vegas	Nevada
United States	Furiex Research Site	Lauderdale Lakes	Florida
United States	Furiex Research Site	Lawrenceville	Georgia
United States	Furiex Research Site	Lebanon	New Hampshire
United States	Furiex Research Site	Lexington	Kentucky
United States	Furiex Research Site	Lexington	Kentucky
United States	Furiex Research Site	Lima	Ohio
United States	Furiex Research Site	Lincoln	Nebraska
United States	Furiex Research Site	Lincoln	California
United States	Furiex Research Site	Little Rock	Arkansas
United States	Furiex Research Site	Loma Linda	California
United States	Furiex Research Site	Lomita	California
United States	Furiex Research Site	Long Beach	California
United States	Furiex Research Site	Los Angeles	California
United States	Furiex Research Site	Macon	Georgia
United States	Furiex Research Site	Marietta	Georgia
United States	Furiex Research Site	Marlton	New Jersey
United States	Furiex Research Site	Melbourne	Florida
United States	Furiex Research Site	Mesa	Arizona
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	Midlothian	Virginia
United States	Furiex Research Site	Mineola	New York
United States	Furiex Research Site	Miramar	Florida
United States	Furiex Research Site	Mobile	Alabama
United States	Furiex Research Site	Monroe	Louisiana
United States	Furiex Research Site	Monroe	Wisconsin
United States	Furiex Research Site	Montgomery	Alabama
United States	Furiex Research Site	Mount Pleasant	South Carolina
United States	Furiex Research Site	New Port Richey	Florida
United States	Furiex Research Site	New York	New York
United States	Furiex Research Site	Newport Beach	California
United States	Furiex Research Site	Norcross	Georgia
United States	Furiex Research Site	Norfolk	Virginia
United States	Furiex Research Site	Norman	Oklahoma
United States	Furiex Research Site	North Hollywood	California
United States	Furiex Research Site	North Myrtle Beach	South Carolina
United States	Furiex Research Site	Northridge	California
United States	Furiex Research Site	Oklahoma City	Oklahoma
United States	Furiex Research Site	Oklahoma City	Oklahoma
United States	Furiex Research Site	Omaha	Nebraska
United States	Furiex Research Site	Omaha	Nebraska
United States	Furiex Research Site	Orlando	Florida
United States	Furiex Research Site	Owensboro	Kentucky
United States	Furiex Research Site	Paducah	Kentucky
United States	Furiex Research Site	Pasadena	California
United States	Furiex Research Site	Philadelphia	Pennsylvania
United States	Furiex Research Site	Phoenix	Arizona
United States	Furiex Research Site	Phoenix	Arizona
United States	Furiex Research Site	Pittsburgh	Pennsylvania
United States	Furiex Research Site	Pittsburgh	Pennsylvania
United States	Furiex Research Site	Plant City	Florida
United States	Furiex Research Site	Plymouth	Minnesota
United States	Furiex Research Site	Port Orange	Florida
United States	Furiex Research Site	Portland	Oregon
United States	Furiex Research Site	Pratt	Kansas
United States	Furiex Research Site	Rapid City	South Dakota
United States	Furiex Research Site	Reno	Nevada
United States	Furiex Research Site	Richmond	Virginia
United States	Furiex Research Site	Richmond	Virginia
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 Louis	Missouri
United States	Furiex Research Site	Saint Peters	Missouri
United States	Furiex Research Site	Saint Petersburg	Florida
United States	Furiex Research Site	Saint Petersburg	Florida
United States	Furiex Research Site	Salem	Oregon
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	Santa Ana	California
United States	Furiex Research Site	Savannah	Georgia
United States	Furiex Research Site	Scottdale	Pennsylvania
United States	Furiex Research Site	Shawnee Mission	Kansas
United States	Furiex Research Site	Sheffield	Alabama
United States	Furiex Research Site	Sherwood	Arkansas
United States	Furiex Research Site	Smyrna	Tennessee
United States	Furiex Research Site	South Miami	Florida
United States	Furiex Research Site	Springfield	Illinois
United States	Furiex Research Site	Stockbridge	Georgia
United States	Furiex Research Site	Tampa	Florida
United States	Furiex Research Site	Tiffin	Ohio
United States	Furiex Research Site	Toledo	Ohio
United States	Furiex Research Site	Topeka	Kansas
United States	Furiex Research Site	Troy	Michigan
United States	Furiex Research Site	Tucson	Arizona
United States	Furiex Research Site	Tucson	Arizona
United States	Furiex Research Site	Tuscaloosa	Alabama
United States	Furiex Research Site	Uniontown	Pennsylvania
United States	Furiex Research Site	Ventura	California
United States	Furiex Research Site	Walnut Creek	California
United States	Furiex Research Site	Warwick	Rhode Island
United States	Furiex Research Site	Watertown	Massachusetts
United States	Furiex Research Site	Wellington	Florida
United States	Furiex Research Site	West Valley City	Utah
United States	Furiex Research Site	Wilmington	North Carolina
United States	Furiex Research Site	Winston-Salem	North Carolina
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	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Furiex Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico,  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 participants 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 participants 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 and 30 (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	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 and 30/EOT