Clinical trial NCT01553747: Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome with diarrhea
Irritable bowel syndrome
Diarrhea predominant irritable bowel syndrome
Colonic diseases
Colonic diseases, functional
Digestive system disease
Gastrointestinal disease
Intestinal disease
Colonic pseudo-obstruction
Diarrhea
Signs and symptoms, Digestive
Lead sponsor: Furiex Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2012-03-14
Enrollment: 1146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores
timeFrame: Up to 26 weeks
measure: Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
timeFrame: 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)
measure: Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
timeFrame: 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)
measure: Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
timeFrame: 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)
measure: Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
timeFrame: Weeks 4, 8, 12, 18, 26 and 30 (End of Treatment [EOT])
measure: Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale
timeFrame: 12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)
measure: Change From Baseline in Daily Abdominal Discomfort Scores
timeFrame: Baseline, Weeks 4, 12 and 26
measure: Change From Baseline in Daily Abdominal Bloating Scores
timeFrame: Baseline, Weeks 4, 12 and 26
measure: Number of Bowel Movements Per Day
timeFrame: Weeks 4, 12 and 26
measure: Number of Bowel Incontinence Episodes
timeFrame: Weeks 4, 12 and 26
measure: Number of Bowel Incontinence Free Days
timeFrame: Weeks 4, 12 and 26
measure: Number of Urgency Episodes Per Day
timeFrame: Weeks 4, 12 and 26
measure: Change From Baseline in IBS-QoL Total Scores
timeFrame: Baseline, Weeks 4, 8, 12, 18, 26 and 30/EOT
Other outcomes:
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city: Richmond
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city: Monroe
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city: Vaughan
country: Canada
facility: Furiex Research Site
state: Ontario
city: San Juan
country: Puerto Rico
facility: Furiex Research Site
city: Chestfield
country: United Kingdom
facility: Furiex Research Site
state: Kent
city: Blackpool
country: United Kingdom
facility: Furiex Research Site
state: Lancashire
city: Birmingham
country: United Kingdom
facility: Furiex Research Site
city: County Durham
country: United Kingdom
facility: Furiex Research Site
city: Coventry
country: United Kingdom
facility: Furiex Research Site
city: Durham
country: United Kingdom
facility: Furiex Research Site
city: Edinburgh
country: United Kingdom
facility: Furiex Research Site
city: Manchester
country: United Kingdom
facility: Furiex Research Site
city: Sheffield
country: United Kingdom
facility: Furiex Research Site
city: Wigan
country: United Kingdom
facility: Furiex Research Site
Study officials:
References:
citation: Fant RV, Henningfield JE, Cash BD, Dove LS, Covington PS. Eluxadoline Demonstrates a Lack of Abuse Potential in Phase 2 and 3 Studies of Patients With Irritable Bowel Syndrome With Diarrhea. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1021-1029.e6. doi: 10.1016/j.cgh.2017.01.026. Epub 2017 Feb 3.
citation: Lembo AJ, Lacy BE, Zuckerman MJ, Schey R, Dove LS, Andrae DA, Davenport JM, McIntyre G, Lopez R, Turner L, Covington PS. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med. 2016 Jan 21;374(3):242-53. doi: 10.1056/NEJMoa1505180.