We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02959983
Recruitment Status : Completed
First Posted : November 9, 2016
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Irritable Bowel Syndrome With Diarrhea
Interventions Drug: Eluxadoline
Drug: Placebo
Enrollment 346
Recruitment Details  
Pre-assignment Details A total of 660 participants were screened; 346 participants were randomized; 344 participants received at least 1 dose of study drug which comprises the safety population. Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study.
Arm/Group Title Eluxadoline Placebo
Hide Arm/Group Description Eluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks. Placebo matching eluxadoline oral tablets BID with food for 12 weeks.
Period Title: Overall Study
Started 172 174
Completed 146 149
Not Completed 26 25
Reason Not Completed
Protocol Violation             0             1
Lack of Efficacy             0             1
Lost to Follow-up             12             9
Other             1             1
Physician Decision             1             0
Adverse Event             5             1
Withdrawal by Subject             7             12
Arm/Group Title Eluxadoline Placebo Total
Hide Arm/Group Description Eluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks. Placebo matching eluxadoline oral tablets BID with food for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 172 174 346
Hide Baseline Analysis Population Description
The Intent-to-Treat population includes all randomized patients.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 174 participants 346 participants
<65
158
  91.9%
161
  92.5%
319
  92.2%
≥65
14
   8.1%
13
   7.5%
27
   7.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 174 participants 346 participants
Female
124
  72.1%
119
  68.4%
243
  70.2%
Male
48
  27.9%
55
  31.6%
103
  29.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 174 participants 346 participants
Hispanic or Latino
33
  19.2%
41
  23.6%
74
  21.4%
Not Hispanic or Latino
139
  80.8%
133
  76.4%
272
  78.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 174 participants 346 participants
Caucasian
144
  83.7%
141
  81.0%
285
  82.4%
Black or African American
20
  11.6%
26
  14.9%
46
  13.3%
Asian
7
   4.1%
3
   1.7%
10
   2.9%
American Indian or Alaskan Native
1
   0.6%
2
   1.1%
3
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.6%
1
   0.3%
Other
0
   0.0%
1
   0.6%
1
   0.3%
1.Primary Outcome
Title Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores
Hide Description Percentage of primary composite responders is defined as the percentage of participants who meet both of the following daily composite criteria for at least 50% of the days with diary entry: 1)Worst Abdominal Pain (WAP) score improved by ≥40% compared to Baseline. The participant records their WAP score in the past 24 hours each day in a daily patient diary where: 0=no pain to 10=worst imaginable pain. 2) Bristol Stool Score (BSS) <5; or the absence of a bowel movement if accompanied by ≥40% improvement in WAP compared to Baseline. The participant records their stool consistency each day in a daily patient diary using the BSS on a scale from 1 (hard stool) to 7 (watery stool).
Time Frame Baseline, Weeks 1 to 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat population includes all randomized patients.
Arm/Group Title Eluxadoline Placebo
Hide Arm/Group Description:
Eluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks.
Placebo matching eluxadoline oral tablets BID with food for 12 weeks.
Overall Number of Participants Analyzed 172 174
Measure Type: Number
Unit of Measure: percentage of participants
22.7 10.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eluxadoline, Placebo
Comments Overall Weeks 1-12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Stool Consistency Responders
Hide Description Percentage of stool consistency responders is defined as the percentage of participants who meet the daily stool consistency response criteria: BSS <5; or the absence of a bowel movement if accompanied by ≥40% improvement in WAP compared to Baseline for ≥50% of days with daily patient diary entries over a certain time period. The participant records their stool consistency each day in a daily patient diary using the BSS on a scale from 1 (hard stool) to 7 (watery stool). A participant must have had a minimum of 20 days of diary entries over any 4-week interval.
Time Frame Weeks 1 to 12 and 4-week intervals (Weeks 1 to 4, Weeks 5 to 8 and Weeks 9 to 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat population includes all randomized patients.
Arm/Group Title Eluxadoline Placebo
Hide Arm/Group Description:
Eluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks.
Placebo matching eluxadoline oral tablets BID with food for 12 weeks.
Overall Number of Participants Analyzed 172 174
Measure Type: Number
Unit of Measure: Percentage of Participants
Overall Weeks 1 to 12 27.9 16.7
Weeks 1 to 4 24.4 12.6
Weeks 5 to 8 30.8 20.1
Weeks 9 to 12 29.7 25.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eluxadoline, Placebo
Comments Overall Weeks 1 to 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0119
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Eluxadoline, Placebo
Comments Weeks 1 to 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Eluxadoline, Placebo
Comments Weeks 5 to 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0207
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Eluxadoline, Placebo
Comments Weeks 9 to 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3700
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Pain Responders
Hide Description Percentage of pain responders is defined as the percentage of participants who meet the daily pain response criteria: WAP score improved by ≥40% compared to Baseline for ≥50% of days with diary entries over a certain time period. The participant records their WAP score in the past 24 hours each day in a daily diary where: 0=no pain to 10=worst imaginable pain. A participant must have had a minimum of 20 days of diary entries over any 4-week interval.
Time Frame Baseline, Weeks 1 to 12 and 4-week intervals (Weeks 1 to 4, Weeks 5 to 8 and Weeks 9 to 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat population includes all randomized patients.
Arm/Group Title Eluxadoline Placebo
Hide Arm/Group Description:
Eluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks.
Placebo matching eluxadoline oral tablets BID with food for 12 weeks.
Overall Number of Participants Analyzed 172 174
Measure Type: Number
Unit of Measure: Percentage of Participants
Overall Weeks 1 to 12 43.6 31.0
Weeks 1 to 4 30.2 25.9
Weeks 5 to 8 45.9 31.6
Weeks 9 to 12 44.8 35.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eluxadoline, Placebo
Comments Overall Weeks 1 to 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0174
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Eluxadoline, Placebo
Comments Weeks 1 to 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3832
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Eluxadoline, Placebo
Comments Weeks 5 to 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0052
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Eluxadoline, Placebo
Comments Weeks 9 to 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0619
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Monthly Composite Responders
Hide Description Percentage of monthly composite responders is defined as the percentage of participants who meet the daily composite response criteria for at least 50% of days with diary entry for a minimum of 20 days during each 4-week interval (weeks 1 to 4, 5 to 8, and 9 to 12). Composite response includes both of the following criteria: 1) WAP score improved by ≥40% compared to Baseline. The participant records their WAP score in the past 24 hours each day in a daily patient diary where: 0=no pain to 10=worst imaginable pain. 2) BSS <5; or the absence of a bowel movement if accompanied by ≥40% improvement in WAP compared to Baseline. The participant records their stool consistency each day in a daily patient diary using the BSS on a scale from 1 (hard stool) to 7 (watery stool).
Time Frame Weeks 1 to 4, 5 to 8, and 9 to 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat population includes all randomized patients.
Arm/Group Title Eluxadoline Placebo
Hide Arm/Group Description:
Eluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks.
Placebo matching eluxadoline oral tablets BID with food for 12 weeks.
Overall Number of Participants Analyzed 172 174
Measure Type: Number
Unit of Measure: Percentage of Participants
Weeks 1-4 14 6.9
Weeks 5-8 26.7 14.9
Weeks 9-12 30.8 16.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eluxadoline, Placebo
Comments Weeks 1-4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0330
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Eluxadoline, Placebo
Comments Weeks 5 to 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Eluxadoline, Placebo
Comments Weeks 9 to 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame Up to 12 weeks
Adverse Event Reporting Description The Safety Population will include all patients enrolled who received at least 1 dose of study drug. Safety data will be analyzed using the safety population.
 
Arm/Group Title Eluxadoline Placebo
Hide Arm/Group Description Eluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks. Placebo matching eluxadoline oral tablets BID with food for 12 weeks.
All-Cause Mortality
Eluxadoline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/171 (0.00%)   0/173 (0.00%) 
Hide Serious Adverse Events
Eluxadoline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/171 (0.58%)   3/173 (1.73%) 
Cardiac disorders     
Cardiac failure congestive  1  0/171 (0.00%)  1/173 (0.58%) 
Gastrointestinal disorders     
Pancreatic mass  1  1/171 (0.58%)  0/173 (0.00%) 
Infections and infestations     
Cellulitis  1  0/171 (0.00%)  1/173 (0.58%) 
Pneumonia  1  0/171 (0.00%)  1/173 (0.58%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma  1  0/171 (0.00%)  1/173 (0.58%) 
Reproductive system and breast disorders     
Dysmenorrhea  1  0/171 (0.00%)  1/173 (0.58%) 
Endometriosis  1  0/171 (0.00%)  1/173 (0.58%) 
Ovarian cyst  1  0/171 (0.00%)  1/173 (0.58%) 
Pelvic pain  1  0/171 (0.00%)  1/173 (0.58%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eluxadoline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   10/171 (5.85%)   5/173 (2.89%) 
Gastrointestinal disorders     
Nausea  1  10/171 (5.85%)  5/173 (2.89%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: IR-CTRegistration@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02959983    
Other Study ID Numbers: CMO-US-GI-0429
First Submitted: November 7, 2016
First Posted: November 9, 2016
Results First Submitted: January 22, 2019
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019