- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03441581
Eluxadoline Bile Acid Malabsorption (BAM) Study
April 28, 2021 updated by: Allergan
3030-401-002: An Open-Label Pilot Study of Eluxadoline in Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D) Who Have Evidence of Bile Acid Malabsorption (BAM)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eluxadoline 100 mg with BAM
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.
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Eluxadoline 100 mg oral tablets BID with food.
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Experimental: Eluxadoline 100 mg without BAM
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
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Eluxadoline 100 mg oral tablets BID with food.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Average Bristol Stool Form Scale (BSFS) Score Over 4 Weeks of Treatment Period
Time Frame: Baseline (Day 1) to Week 4
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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.
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Baseline (Day 1) to Week 4
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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Baseline (Day 1) to Week 4
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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.
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Baseline (Day 1) to Week 4
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Number of Participants Who Experienced Potentially Clinically Significant Change in Laboratory Tests
Time Frame: Baseline (Day 1) to Week 4
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Laboratory tests included tests of Clinical Chemistry, Hematology, and Urinalysis.
The investigator determined if the result was potentially clinically significant.
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Baseline (Day 1) to Week 4
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Number of Participants Who Experienced Potentially Clinically Significant Change in Vital Signs
Time Frame: Baseline (Day 1) to Week 4
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Vital signs assessments included: pulse, respiratory rate, and blood pressure (systolic and diastolic).
The investigator determined if the result was potentially clinically significant.
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Baseline (Day 1) to Week 4
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Number of Participants Who Experienced Clinically Significant Change From Baseline in General Physical Condition as Measured Through General Physical Exam
Time Frame: Baseline (Day 1) to Week 4
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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.
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Baseline (Day 1) to Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the 4-week Average of Daily Bowel Movement Frequency During the Treatment Period
Time Frame: Baseline (Day 1) to Week 4
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Bowel movements were recorded by the participant in an electronic diary (e-diary).
The number of bowel movements per day was averaged over the 4-week period.
A negative change from Baseline indicates improvement.
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Baseline (Day 1) to Week 4
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Change From Baseline in the 4-week Average of Daily Worst Abdominal Pain Scores During the Treatment Period
Time Frame: Baseline (Day 1) to Week 4
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The participant recorded their worst abdominal pain score in the past 24 hours each day in an e-diary where: 0=no pain to 10=worst imaginable pain.
The score each day was averaged over the 4-week period.
A negative change from Baseline indicates improvement.
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Baseline (Day 1) to Week 4
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Change From Baseline in the 4-week Average of Daily Bloating Scores During the Treatment Period
Time Frame: Baseline (Day 1) to Week 4
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The participant recorded their bloating score in the past 24 hours each day in an e-diary where: 0=no bloating to 10=worst imaginable bloating.
The score each day was averaged over the 4-week period.
A negative change from Baseline indicates improvement.
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Baseline (Day 1) to Week 4
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Change From Baseline in the 4-week Average Number of Daily Urgent Bowel Movements During the Treatment Period
Time Frame: Baseline (Day 1) to Week 4
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The participant recorded the number of urgent bowel movements in the past 24 hours each day in an e-diary.
The number of urgent bowel movements per day was averaged over the 4-week period.
A negative change from Baseline indicates improvement.
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Baseline (Day 1) to Week 4
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Percentage of Participants With Any Fecal Incontinence During the Treatment Period
Time Frame: Baseline (Day 1) to Week 4
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The participant recorded the number of fecal incontinences in the past 24 hours each day in an e-diary.
Fecal incontinence is the inability to control the passage of gas or stools.
The number of fecal incontinences per day was averaged over the 4-week period.
A negative change from Baseline indicates improvement.
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Baseline (Day 1) to Week 4
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Change From Baseline in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at the End of the Treatment Period
Time Frame: Baseline (Day1) to End of Treatment (Up to Week 4)
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IBS-QOL is composed of 34 items about how the symptoms of IBS are impacting the participant's life scored on a 1 to 5 scale, where lower item scores indicate greater quality of life.
The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0 to 100-point scale (0=worst; 100=better) for ease of interpretation.
A positive change from Baseline indicates improved quality of life.
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Baseline (Day1) to End of Treatment (Up to Week 4)
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Change From Baseline in Fasting Serum 7α-hydroxy-4-cholesten-3-one (7αC4) Levels at the End of the Treatment Period
Time Frame: Baseline (Day 1) to End of Treatment (Up to Week 4)
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Participants fasted for at least 8 hours prior to the test.
Fasting serum 7αC4 level was measured at Baseline and End of Treatment to determine whether any changes occurred following treatment with eluxadoline.
The negative change from Baseline indicates improvement.
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Baseline (Day 1) to End of Treatment (Up to Week 4)
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Cmax: Maximum Concentration for Eluxadoline
Time Frame: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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Cmin: Minimum Concentration for Eluxadoline
Time Frame: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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AUC: Area Under the Concentration-time Curve During the Dosing Interval for Eluxadoline
Time Frame: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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Tmax: Time to Cmax for Eluxadoline
Time Frame: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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t1/2: Half-Life for Eluxadoline
Time Frame: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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CL/F: Apparent Total Clearance of the Drug From Plasma After Oral Administration for Eluxadoline
Time Frame: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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Vc/F: Apparent Volume of Distribution for Eluxadoline
Time Frame: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 23, 2018
Primary Completion (Actual)
April 28, 2020
Study Completion (Actual)
April 28, 2020
Study Registration Dates
First Submitted
January 19, 2018
First Submitted That Met QC Criteria
February 15, 2018
First Posted (Actual)
February 22, 2018
Study Record Updates
Last Update Posted (Actual)
May 19, 2021
Last Update Submitted That Met QC Criteria
April 28, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3030-401-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Eluxadoline
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AllerganCompletedIrritable Bowel Syndrome With DiarrheaUnited States, Canada
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Furiex Pharmaceuticals, IncCompletedIrritable Bowel SyndromeUnited States, Canada, United Kingdom
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Furiex Pharmaceuticals, IncCompletedIrritable Bowel SyndromeUnited States
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University of North Carolina, Chapel HillNational Institute of Environmental Health Sciences (NIEHS)CompletedAllergic AsthmaUnited States
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