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

F

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

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

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).

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

  • Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
  • 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.
  • Participant has a history of diverticulitis within 3 months prior to Prescreening.
  • 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).

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

Trial contacts and locations

283

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Data sourced from clinicaltrials.gov

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