Irritable Bowel Syndrome With DiarrheaPhase 4NCT03441581
Eluxadoline Bile Acid Malabsorption (BAM) Study
A Phase 4 study testing Eluxadoline in people with Irritable Bowel Syndrome With Diarrhea, run by Allergan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- Eluxadoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2018to 28 Apr 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Being tested
- Eluxadoline
- Keywords
- IBS-D, BAM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EluxadolineDrug
Eluxadoline 100 mg oral tablets BID with food.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Eluxadoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Baseline (Day 1) to Week 4
Change From Baseline in the 4-week Average of Daily Worst Abdominal Pain Scores During the Treatment Period
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.
Measured: Baseline (Day 1) to Week 4
Change From Baseline in the 4-week Average of Daily Bloating Scores During the Treatment Period
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.
Measured: Baseline (Day 1) to Week 4
Change From Baseline in the 4-week Average Number of Daily Urgent Bowel Movements During the Treatment Period
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.
Measured: Baseline (Day 1) to Week 4
Percentage of Participants With Any Fecal Incontinence During the Treatment Period
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.
Measured: Baseline (Day 1) to Week 4
Change From Baseline in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at the End of the Treatment Period
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.
Measured: Baseline (Day1) to End of Treatment (Up to Week 4)
Change From Baseline in Fasting Serum 7α-hydroxy-4-cholesten-3-one (7αC4) Levels at the End of the Treatment Period
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.
Measured: Baseline (Day 1) to End of Treatment (Up to Week 4)
Cmax: Maximum Concentration for Eluxadoline
Measured: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
Cmin: Minimum Concentration for Eluxadoline
Measured: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
AUC: Area Under the Concentration-time Curve During the Dosing Interval for Eluxadoline
Measured: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
Tmax: Time to Cmax for Eluxadoline
Measured: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
t1/2: Half-Life for Eluxadoline
Measured: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
CL/F: Apparent Total Clearance of the Drug From Plasma After Oral Administration for Eluxadoline
Measured: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
Vc/F: Apparent Volume of Distribution for Eluxadoline
Measured: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start23 Feb 2018
- Primary completion28 Apr 2020
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Muslin, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441581
- Sponsor's protocol ID
- 3030-401-002
- Status last verified
- Apr 2021
- First submitted
- 19 Jan 2018
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03441581
- Acronym / sponsor ID
- 3030-401-002
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Keywords
- IBS-D, BAM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 19 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eluxadoline 100 mg with BAM | Experimental | Drug: EluxadolineIBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks. |
| Eluxadoline 100 mg without BAM | Experimental | Drug: EluxadolineIBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EluxadolineEluxadoline 100 mg oral tablets BID with food. | Drug | Eluxadoline 100 mg with BAM, Eluxadoline 100 mg without BAM |
Primary outcome
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
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.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline (Day 1) to Week 4
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.
Number of Participants Who Experienced Potentially Clinically Significant Change in Laboratory Tests
Time frame: Baseline (Day 1) to Week 4
Laboratory tests included tests of Clinical Chemistry, Hematology, and Urinalysis. The investigator determined if the result was potentially clinically significant.
Number of Participants Who Experienced Potentially Clinically Significant Change in Vital Signs
Time frame: Baseline (Day 1) to Week 4
Vital signs assessments included: pulse, respiratory rate, and blood pressure (systolic and diastolic). The investigator determined if the result was potentially clinically significant.
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
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.
14 secondary outcomes
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
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
Change From Baseline in the 4-week Average of Daily Bloating Scores During the Treatment Period
Time frame: Baseline (Day 1) to Week 4
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
Percentage of Participants With Any Fecal Incontinence During the Treatment Period
Time frame: Baseline (Day 1) to Week 4
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)
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)
Cmax: Maximum Concentration for Eluxadoline
Time frame: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
Cmin: Minimum Concentration for Eluxadoline
Time frame: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Muslin study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eluxadoline in people with Irritable Bowel Syndrome With Diarrhea, run by Allergan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.