Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea

Furiex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Eluxadoline; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01130272

27018966IBS2001

Details and patient eligibility

About

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

Enrollment: 807 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea
• Female patients must be:
• postmenopausal, defined as amenorrhea 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.

Key Exclusion Criteria:

• Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation, mixed IBS, or unsubtyped IBS
• Patient has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease
• Patient has a history of diverticulitis within 6 months prior to Prescreening
• Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of a major vein, or hypercoagulable states.

Other protocol-specific eligibility criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

807 participants in 5 patient groups, including a placebo group

Eluxadoline 5 mg

Experimental group

Description:

Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.

Treatment:

Drug: Eluxadoline

Eluxadoline 25 mg

Experimental group

Description:

Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. .

Treatment:

Drug: Eluxadoline

Eluxadoline 100 mg

Experimental group

Description:

Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.

Treatment:

Drug: Eluxadoline

Eluxadoline 200 mg

Experimental group

Description:

Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.

Treatment:

Drug: Eluxadoline

Placebo

Placebo Comparator group

Description:

Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.

Treatment:

Drug: Placebo