Eluxadoline Bile Acid Malabsorption (BAM) Study

Allergan

Status and phase: Completed; Phase 4

Conditions: Irritable Bowel Syndrome With Diarrhea

Treatments: Drug: Eluxadoline

Study type: Interventional

Funder types: Industry

Identifiers

NCT03441581

3030-401-002

Details and patient eligibility

About

This study will evaluate the possibility of a differential effect of eluxadoline on altered bowel function in Irritable Bowel Syndrome with Diarrhea (IBS-D) participants with and without evidence of Bile Acid Malabsorption (BAM).

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult men or women aged 18 to 75 years inclusive with a diagnosis of IBS-D per Rome IV criteria.
• Participants with evidence of BAM must have a fasting serum 7a-hydroxy-4-cholesten-3-one (7αC4) level ≥ 52.5 ng/mL or total fecal bile acid (BA) > 2337 micromoles/48 hours (positive result) at screening or within 1 calendar year prior to screening.
• Participants without BAM must have a fasting serum 7αC4 level ≤ 47.1 ng/mL or total fecal BA < 2200 micromoles/48 hours (negative result) at screening or within 1 calendar year prior to screening.
• Has an average daily Bristol Stool Form Scale (BSFS) score ≥ 5.0 or ≥ 25% of diary entry days with a BSFS score of 6 or 7 during the 14 days prior to Day 1.
• Women of childbearing potential must use hormonal or double barrier contraception or maintain a monogamous relationship with a vasectomized male partner from the date of informed consent until 24 hours after final dose of study drug.
• Completed the electronic diary (eDiary) on ≥ 10 of the 14 days prior to Day 1.
• Has not used loperamide rescue medication on > 3 of the 14 days prior to Day 1.

Exclusion criteria

• Has a diagnosis of IBS with a subtype of irritable bowel syndrome with constipation (IBS-C), mixed IBS, or unsubtyped IBS per Rome IV criteria.
• Does not have a gallbladder.
• Has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction. (Participants with a history of gallstones may be enrolled).
• Has a history of alcoholism, alcohol abuse or alcohol addiction, or drinks more than 3 alcoholic beverages per day.
• Has a history of pancreatitis; structural diseases of the pancreas, including known or suspected pancreatic duct obstruction.
• Has a history of mild, moderate, or severe hepatic impairment according to Child-Pugh classification. History or current diagnosis of inflammatory or immune-mediated gastrointestinal (GI) disorders.
• Has Celiac disease or a positive serological test for celiac disease.
• Has known lactose or fructose intolerance associated with diarrhea, abdominal pain or discomfort, that could confound assessments in the study.
• Women who are currently pregnant or nursing, or plan to become pregnant or nurse during the study.
• Has known allergies or hypersensitivity to opioids.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Eluxadoline 100 mg with BAM

Experimental group

Description:

IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.

Treatment:

Drug: Eluxadoline

Eluxadoline 100 mg without BAM

Experimental group

Description:

IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.

Treatment:

Drug: Eluxadoline