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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eluxadoline | Drug | Eluxadoline 100 mg oral tablets BID with food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1) to Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Muslin | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population included of all participants who received ≥ 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Eluxadoline 100 mg Without BAM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified Intent-to-Treat (mITT) Population included of all participants in Enrolled Population with ≥ 1 postbaseline assessment for BSFS. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) to Week 4 |
|
Up to 6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | MedDRA: 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan | 714-246-4500 | IR-CTRegistration@allergan.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2019 | Apr 28, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2020 | Apr 28, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C583636 | eluxadoline |
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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. |
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline (Day 1) to End of Treatment (Up to Week 4) |
| Cmax: Maximum Concentration for Eluxadoline | Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2 |
| Cmin: Minimum Concentration for Eluxadoline | 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 | Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2 |
| Tmax: Time to Cmax for Eluxadoline | Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2 |
| t1/2: Half-Life for Eluxadoline | 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 | 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 | Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2 |
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| 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. |
|
|
| Primary | 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. | Safety Population included of all participants who received ≥ 1 dose of study treatment. | Posted | Number | percentage of participants | Baseline (Day 1) to Week 4 |
|
|
|
| Primary | 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. | Safety Population included of all participants who received ≥ 1 dose of study treatment. | Posted | Count of Participants | Participants | Baseline (Day 1) to Week 4 |
|
|
|
| Primary | 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. | Safety Population included of all participants who received ≥ 1 dose of study treatment. | Posted | Count of Participants | Participants | Baseline (Day 1) to Week 4 |
|
|
|
| Primary | 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. | Safety Population included of all participants who received ≥ 1 dose of study treatment. | Posted | Count of Participants | Participants | Baseline (Day 1) to Week 4 |
|
|
|
| Secondary | 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. | mITT Population included of all participants in enrolled population with ≥ 1 postbaseline assessment for BSFS. | Posted | Mean | Standard Deviation | bowel movements per day | Baseline (Day 1) to Week 4 |
|
|
|
| Secondary | 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. | mITT Population included of all participants in enrolled population with ≥ 1 postbaseline assessment for BSFS. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) to Week 4 |
|
|
|
| Secondary | 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. | mITT Population included of all participants in enrolled population with ≥ 1 postbaseline assessment for BSFS. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) to Week 4 |
|
|
|
| Secondary | 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. | mITT Population included of all participants in enrolled population with ≥ 1 postbaseline assessment for BSFS. | Posted | Mean | Standard Deviation | urgent bowel movements per day | Baseline (Day 1) to Week 4 |
|
|
|
| Secondary | 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. | mITT Population included of all participants in enrolled population with ≥ 1 postbaseline assessment for BSFS. | Posted | Number | percentage of participants | Baseline (Day 1) to Week 4 |
|
|
|
| Secondary | 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. | mITT Population included of all participants in enrolled population with ≥ 1 postbaseline assessment for BSFS. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day1) to End of Treatment (Up to Week 4) |
|
|
|
| Secondary | 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. | mITT Population included of all participants in enrolled population with ≥ 1 postbaseline assessment for BSFS. Number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | Baseline (Day 1) to End of Treatment (Up to Week 4) |
|
|
|
| Secondary | Cmax: Maximum Concentration for Eluxadoline | Pharmacokinetic (PK) population included all participants in the enrolled population and whose dry blood sample (DBS) was collected. | Posted | Mean | Standard Deviation | ng/mL | Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2 |
|
|
|
| Secondary | Cmin: Minimum Concentration for Eluxadoline | PK population included all participants in the enrolled population and whose DBS was collected. | Posted | Mean | Standard Deviation | ng/mL | Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2 |
|
|
|
| Secondary | AUC: Area Under the Concentration-time Curve During the Dosing Interval for Eluxadoline | PK population included all participants in the enrolled population and whose DBS was collected. | Posted | Mean | Standard Deviation | nanogram* hour/milliliter (ng*h/mL) | Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2 |
|
|
|
| Secondary | Tmax: Time to Cmax for Eluxadoline | PK population included all participants in the enrolled population and whose DBS was collected. | Posted | Median | Full Range | hours (h) | Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2 |
|
|
|
| Secondary | t1/2: Half-Life for Eluxadoline | PK population included all participants in the enrolled population and whose DBS was collected. | Posted | Median | Full Range | h | Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2 |
|
|
|
| Secondary | CL/F: Apparent Total Clearance of the Drug From Plasma After Oral Administration for Eluxadoline | PK population included all participants in the enrolled population and whose DBS was collected. | Posted | Mean | Standard Deviation | liter/hour (L/h) | Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2 |
|
|
|
| Secondary | Vc/F: Apparent Volume of Distribution for Eluxadoline | PK population included all participants in the enrolled population and whose DBS was collected. | Posted | Mean | Standard Deviation | L | Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 11 |
| 12 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 7 | 12 |
| Abdominal pain | Gastrointestinal disorders | MedDRA: 23.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA: 23.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA: 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA: 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA: 23.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA: 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA: 23.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA: 23.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA: 23.0 | Systematic Assessment |
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| Bowel movement irregularity | Gastrointestinal disorders | MedDRA: 23.0 | Systematic Assessment |
|
| Dyschezia | Gastrointestinal disorders | MedDRA: 23.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA: 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA: 23.0 | Systematic Assessment |
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| Impaired fasting glucose | Metabolism and nutrition disorders | MedDRA: 23.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA: 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA: 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA: 23.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA: 23.0 | Systematic Assessment |
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| Hypotonia | Nervous system disorders | MedDRA: 23.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA: 23.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA: 23.0 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Change from Baseline at End of Treatment |
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|