Phase 4
N=24
Eluxadoline Bile Acid Malabsorption (BAM) Study
Irritable Bowel Syndrome With Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT03441581 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Change From Baseline in Average Bristol Stool Form Scale (BSFS) Score Over 4 Weeks of Treatment Period — 5.89; 5.34; -1.25; -1.09 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Eluxadoline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Bristol Stool Form Scale (BSFS) Score Over 4 Weeks of Treatment Period |
5.89; 5.34; -1.25; -1.09 | — |
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
91.7; 58.3 | — |
| PRIMARY Number of Participants Who Experienced Potentially Clinically Significant Change in Laboratory Tests |
0; 2 | — |
| PRIMARY Number of Participants Who Experienced Potentially Clinically Significant Change in Vital Signs |
0; 1 | — |
| PRIMARY Number of Participants Who Experienced Clinically Significant Change From Baseline in General Physical Condition as Measured Through General Physical Exam |
0; 0 | — |
| SECONDARY Change From Baseline in the 4-week Average of Daily Bowel Movement Frequency During the Treatment Period |
4.18; 2.86; -1.48; -0.79 | — |
| SECONDARY Change From Baseline in the 4-week Average of Daily Worst Abdominal Pain Scores During the Treatment Period |
1.77; 3.13; -0.12; -1.28 | — |
| SECONDARY Change From Baseline in the 4-week Average of Daily Bloating Scores During the Treatment Period |
2.31; 4.07; -0.47; -1.46 | — |
| SECONDARY Change From Baseline in the 4-week Average Number of Daily Urgent Bowel Movements During the Treatment Period |
1.67; 1.22; -0.52; -0.80 | — |
| SECONDARY Percentage of Participants With Any Fecal Incontinence During the Treatment Period |
33.3; 33.3 | — |
| SECONDARY Change From Baseline in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at the End of the Treatment Period |
75.1; 71.4; 8.8; 13.2 | — |
| SECONDARY Change From Baseline in Fasting Serum 7α-hydroxy-4-cholesten-3-one (7αC4) Levels at the End of the Treatment Period |
42.95; 30.58; -5.59; -8.78 | — |
| SECONDARY Cmax: Maximum Concentration for Eluxadoline |
1.40; 0.91 | — |
| SECONDARY Cmin: Minimum Concentration for Eluxadoline |
0.39; 0.42 | — |
| SECONDARY AUC: Area Under the Concentration-time Curve During the Dosing Interval for Eluxadoline |
9.22; 7.75 | — |
| SECONDARY Tmax: Time to Cmax for Eluxadoline |
1.5; 2.0 | — |
| SECONDARY t1/2: Half-Life for Eluxadoline |
30.5; 35.2 | — |
| SECONDARY CL/F: Apparent Total Clearance of the Drug From Plasma After Oral Administration for Eluxadoline |
20236; 21901 | — |
| SECONDARY Vc/F: Apparent Volume of Distribution for Eluxadoline |
29432; 39799 | — |
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).
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT03441581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.