Eluxadoline Bile Acid Malabsorption (BAM) Study

NCT03441581 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 3030-401-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Irritable Bowel Syndrome With Diarrhea

Keywords

IBS-D; BAM

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in Average Bristol Stool Form Scale (BSFS) Score Over 4 Weeks of Treatment Period

  Stool consistency was assessed using the BSFS where: 1=Separate hard lumps like nuts to 7=Watery. The score was recorded by the participant in an electronic diary (e-diary). The score for each day was averaged over the 4-week period. A negative change from Baseline indicates improvement.

  Baseline (Day 1) to Week 4

• Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug.

  Baseline (Day 1) to Week 4

• Number of Participants Who Experienced Potentially Clinically Significant Change in Laboratory Tests

  Laboratory tests included tests of Clinical Chemistry, Hematology, and Urinalysis. The investigator determined if the result was potentially clinically significant.

  Baseline (Day 1) to Week 4

• Number of Participants Who Experienced Potentially Clinically Significant Change in Vital Signs

  Vital signs assessments included: pulse, respiratory rate, and blood pressure (systolic and diastolic). The investigator determined if the result was potentially clinically significant.

  Baseline (Day 1) to Week 4

• Number of Participants Who Experienced Clinically Significant Change From Baseline in General Physical Condition as Measured Through General Physical Exam

  General Physical Examination consisted of a full review of body systems excluding pelvic and rectal exams. The investigator determined if the result was clinically significant.

  Baseline (Day 1) to Week 4

Secondary Outcomes (14)

• Change From Baseline in the 4-week Average of Daily Bowel Movement Frequency During the Treatment Period

  Baseline (Day 1) to Week 4

• Change From Baseline in the 4-week Average of Daily Worst Abdominal Pain Scores During the Treatment Period

  Baseline (Day 1) to Week 4

• Change From Baseline in the 4-week Average of Daily Bloating Scores During the Treatment Period

  Baseline (Day 1) to Week 4

• Change From Baseline in the 4-week Average Number of Daily Urgent Bowel Movements During the Treatment Period

  Baseline (Day 1) to Week 4

• Percentage of Participants With Any Fecal Incontinence During the Treatment Period

  Baseline (Day 1) to Week 4

Study Arms (2)

Eluxadoline 100 mg with BAM

EXPERIMENTAL

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.

Drug: Eluxadoline

Eluxadoline 100 mg without BAM

EXPERIMENTAL

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

Drug: Eluxadoline

Interventions

Eluxadoline DRUG

Eluxadoline 100 mg oral tablets BID with food.

Eluxadoline 100 mg with BAM; Eluxadoline 100 mg without BAM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

eluxadoline

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan

IR-CTRegistration@allergan.com

714-246-4500

Study Officials

• Anna Muslin

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 22, 2018
• Study Start: February 23, 2018
• Primary Completion: April 28, 2020
• Study Completion: April 28, 2020
• Last Updated: May 19, 2021
• Results First Posted: May 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)