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CompletedNCT03441581Updated May 19, 2021Results posted

Eluxadoline Bile Acid Malabsorption (BAM) Study

A Phase 4 interventional study of Eluxadoline in Irritable Bowel Syndrome With Diarrhea, sponsored by Allergan. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-05-19.

Sponsored by Allergan (part of AbbVie) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Irritable Bowel Syndrome With Diarrhea

Keywords

  • IBS-D
  • BAM
03

In context

Diarrhea

877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.

This study's enrollment of 24 is below the median of 137 across 738 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.

First submitted before Allergan became part of AbbVie.

Browse Allergan studies →All AbbVie studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 must use hormonal or double barrier or maintain a monogamous relationship with a vasectomized male partner from the date of 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

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 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 to opioids.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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.

    Drug: Eluxadoline

  • 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.

    Drug: Eluxadoline

Interventions

  • DrugEluxadoline

    Eluxadoline 100 mg oral tablets BID with food.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (Day 1) to Week 4

  2. 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.

    Time frame: Baseline (Day 1) to Week 4

  3. 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.

    Time frame: Baseline (Day 1) to Week 4

  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.

    Time frame: Baseline (Day 1) to Week 4

  5. 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.

    Time frame: Baseline (Day 1) to Week 4

Secondary outcomes

  1. 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.

    Time frame: Baseline (Day 1) to Week 4

  2. 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.

    Time frame: Baseline (Day 1) to Week 4

  3. 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.

    Time frame: Baseline (Day 1) to Week 4

  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.

    Time frame: Baseline (Day 1) to Week 4

  5. 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.

    Time frame: Baseline (Day 1) to Week 4

  6. 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.

    Time frame: Baseline (Day1) to End of Treatment (Up to Week 4)

  7. 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.

    Time frame: Baseline (Day 1) to End of Treatment (Up to Week 4)

  8. Cmax: Maximum Concentration for Eluxadoline

    Time frame: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2

  9. Cmin: Minimum Concentration for Eluxadoline

    Time frame: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

07

Results

Posted May 19, 2021

Participant flow

Participant flow — Overall Study
MilestoneEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Started1212
Completed1212
Not completed00

Outcome measures

PrimaryChange 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.

Time frame:
Baseline (Day 1) to Week 4
Reported as:
Mean · score on a scale
Change From Baseline in Average Bristol Stool Form Scale (BSFS) Score Over 4 Weeks of Treatment Period
score on a scaleEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Baseline5.89 ± 0.6395.34 ± 0.777
Change From Baseline at Week 4-1.25 ± 0.914-1.09 ± 0.902
PrimaryPercentage 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.

Time frame:
Baseline (Day 1) to Week 4
Reported as:
Number · percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
percentage of participantsEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)91.758.3
PrimaryNumber 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.

Time frame:
Baseline (Day 1) to Week 4
Reported as:
Count of participants · Participants
Number of Participants Who Experienced Potentially Clinically Significant Change in Laboratory Tests
ParticipantsEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Number of Participants Who Experienced Potentially Clinically Significant Change in Laboratory Tests02
PrimaryNumber 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.

Time frame:
Baseline (Day 1) to Week 4
Reported as:
Count of participants · Participants
Number of Participants Who Experienced Potentially Clinically Significant Change in Vital Signs
ParticipantsEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Number of Participants Who Experienced Potentially Clinically Significant Change in Vital Signs01
PrimaryNumber 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.

Time frame:
Baseline (Day 1) to Week 4
Reported as:
Count of participants · Participants
Number of Participants Who Experienced Clinically Significant Change From Baseline in General Physical Condition as Measured Through General Physical Exam
ParticipantsEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Number of Participants Who Experienced Clinically Significant Change From Baseline in General Physical Condition as Measured Through General Physical Exam00
SecondaryChange 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.

Time frame:
Baseline (Day 1) to Week 4
Reported as:
Mean · bowel movements per day
Change From Baseline in the 4-week Average of Daily Bowel Movement Frequency During the Treatment Period
bowel movements per dayEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Baseline4.18 ± 2.7922.86 ± 1.071
Change from Baseline at Week 4-1.48 ± 1.509-0.79 ± 0.420
SecondaryChange 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.

Time frame:
Baseline (Day 1) to Week 4
Reported as:
Mean · score on a scale
Change From Baseline in the 4-week Average of Daily Worst Abdominal Pain Scores During the Treatment Period
score on a scaleEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Baseline1.77 ± 1.5103.13 ± 1.755
Change from Baseline at Week 4-0.12 ± 0.769-1.28 ± 1.004
SecondaryChange 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.

Time frame:
Baseline (Day 1) to Week 4
Reported as:
Mean · score on a scale
Change From Baseline in the 4-week Average of Daily Bloating Scores During the Treatment Period
score on a scaleEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Baseline2.31 ± 2.2914.07 ± 2.496
Change from Baseline at Week 4-0.47 ± 1.572-1.46 ± 1.297
SecondaryChange 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.

Time frame:
Baseline (Day 1) to Week 4
Reported as:
Mean · urgent bowel movements per day
Change From Baseline in the 4-week Average Number of Daily Urgent Bowel Movements During the Treatment Period
urgent bowel movements per dayEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Baseline1.67 ± 1.1791.22 ± 0.652
Change from Baseline at Week 4-0.52 ± 0.736-0.80 ± 0.651
SecondaryPercentage 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.

Time frame:
Baseline (Day 1) to Week 4
Reported as:
Number · percentage of participants
Percentage of Participants With Any Fecal Incontinence During the Treatment Period
percentage of participantsEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Percentage of Participants With Any Fecal Incontinence During the Treatment Period33.333.3
SecondaryChange 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.

Time frame:
Baseline (Day1) to End of Treatment (Up to Week 4)
Reported as:
Mean · score on a scale
Change From Baseline in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at the End of the Treatment Period
score on a scaleEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Baseline75.1 ± 14.4371.4 ± 13.42
Change from Baseline at Week 48.8 ± 11.7013.2 ± 10.63
SecondaryChange 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.

Time frame:
Baseline (Day 1) to End of Treatment (Up to Week 4)
Reported as:
Mean · nanogram/milliliter (ng/mL)
Change From Baseline in Fasting Serum 7α-hydroxy-4-cholesten-3-one (7αC4) Levels at the End of the Treatment Period
nanogram/milliliter (ng/mL)Eluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Baseline42.95 ± 27.25930.58 ± 17.248
Change from Baseline at End of Treatment-5.59 ± 32.841-8.78 ± 12.050
SecondaryCmax: Maximum Concentration for Eluxadoline
Time frame:
Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
Reported as:
Mean · ng/mL
Cmax: Maximum Concentration for Eluxadoline
ng/mLEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Cmax: Maximum Concentration for Eluxadoline1.40 ± 1.340.91 ± 0.80
SecondaryCmin: Minimum Concentration for Eluxadoline
Time frame:
Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
Reported as:
Mean · ng/mL
Cmin: Minimum Concentration for Eluxadoline
ng/mLEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Cmin: Minimum Concentration for Eluxadoline0.39 ± 0.440.42 ± 0.59
SecondaryAUC: 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
Reported as:
Mean · nanogram* hour/milliliter (ng*h/mL)
AUC: Area Under the Concentration-time Curve During the Dosing Interval for Eluxadoline
nanogram* hour/milliliter (ng*h/mL)Eluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
AUC: Area Under the Concentration-time Curve During the Dosing Interval for Eluxadoline9.22 ± 8.467.75 ± 8.48
SecondaryTmax: Time to Cmax for Eluxadoline
Time frame:
Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
Reported as:
Median · hours (h)
Tmax: Time to Cmax for Eluxadoline
hours (h)Eluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Tmax: Time to Cmax for Eluxadoline1.5 (1.0 to 2.5)2.0 (1.0 to 3.0)
Secondaryt1/2: Half-Life for Eluxadoline
Time frame:
Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2
Reported as:
Median · h
t1/2: Half-Life for Eluxadoline
hEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
t1/2: Half-Life for Eluxadoline30.5 (24.7 to 58.1)35.2 (24.7 to 88.6)
SecondaryCL/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
Reported as:
Mean · liter/hour (L/h)
CL/F: Apparent Total Clearance of the Drug From Plasma After Oral Administration for Eluxadoline
liter/hour (L/h)Eluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
CL/F: Apparent Total Clearance of the Drug From Plasma After Oral Administration for Eluxadoline20236 ± 1328021901 ± 11921
SecondaryVc/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
Reported as:
Mean · L
Vc/F: Apparent Volume of Distribution for Eluxadoline
LEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Vc/F: Apparent Volume of Distribution for Eluxadoline29432 ± 1100039799 ± 10637

Adverse events

Collected over Up to 6 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Eluxadoline 100 mg With BAM0/12 (0%)0/12 (0%)11/12 (91.7%)
Eluxadoline 100 mg Without BAM0/12 (0%)0/12 (0%)7/12 (58.3%)
Most frequent other events
Showing 10 of 22
Most frequent other events
EventEluxadoline 100 mg With BAMEluxadoline 100 mg Without BAM
Abdominal painGastrointestinal disorders6/121/12
FlatulenceGastrointestinal disorders2/124/12
NauseaGastrointestinal disorders4/121/12
Abdominal distensionGastrointestinal disorders2/123/12
ConstipationGastrointestinal disorders1/122/12
Abdominal discomfortGastrointestinal disorders2/120/12
DiarrhoeaGastrointestinal disorders2/120/12
Dry mouthGastrointestinal disorders2/120/12
DyspepsiaGastrointestinal disorders2/120/12
DizzinessNervous system disorders2/120/12

Baseline characteristics

Safety Population included of all participants who received ≥ 1 dose of study treatment.

Age, Continuous
Age, Continuous(years)Eluxadoline 100 mg With BAMEluxadoline 100 mg Without BAMTotal
Mean41.6 ± 6.0740.2 ± 13.7240.9 ± 10.40
Sex: Female, Male
Sex: Female, Male(Participants)Eluxadoline 100 mg With BAMEluxadoline 100 mg Without BAMTotal
Female7916
Male538
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Eluxadoline 100 mg With BAMEluxadoline 100 mg Without BAMTotal
Hispanic or Latino011
Not Hispanic or Latino121123
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Eluxadoline 100 mg With BAMEluxadoline 100 mg Without BAMTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American011
White121123
More than one race000
Unknown or Not Reported000
08

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Apr 2020, 26 months.

Results were first posted in May 2021, 1 year after primary completion.

Of 37 phase 4 interventional studies under Diarrhea, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's 26 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2018
First posted
Feb 22, 2018
StartActual
Feb 23, 2018
Primary completionActual
Apr 28, 2020
CompletionActual
Apr 28, 2020
Results first posted
May 19, 2021
Last update
May 19, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03441581
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Feb 23, 2018
Primary completion
Apr 28, 2020
Completion
Apr 28, 2020
Results posted
May 19, 2021
Last update
May 19, 2021

Study contacts

Anna Muslin
study director · Allergan

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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