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

Furiex Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Placebo; Drug: Eluxadoline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01553591

2012-001600-38 (EudraCT Number)

27018966IBS3001

Details and patient eligibility

About

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.

Enrollment: 1,282 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

1,282 participants in 3 patient groups, including a placebo group

Eluxadoline 75 mg

Experimental group

Description:

Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.

Treatment:

Drug: Eluxadoline

Eluxadoline 100 mg

Experimental group

Description:

Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.

Treatment:

Drug: Eluxadoline

Placebo

Placebo Comparator group

Description:

Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.

Treatment:

Drug: Placebo