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Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea

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ClinicalTrials.gov Identifier: NCT01130272
Recruitment Status : Completed
First Posted : May 25, 2010
Results First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Furiex Pharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE May 24, 2010
First Posted Date  ICMJE May 25, 2010
Results First Submitted Date  ICMJE August 22, 2019
Results First Posted Date  ICMJE October 22, 2019
Last Update Posted Date October 22, 2019
Actual Study Start Date  ICMJE April 28, 2010
Actual Primary Completion Date July 14, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
  • Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 4 [ Time Frame: Baseline (Week prior to Randomization) to Week 4 ]
    Composite responders were defined as participants who completed at least 5 out of 7 days with diary entries during the interval of interest and met both of the following criteria: 1) Average daily pain response scores over the past week improved by ≥30% and at least 2 points as compared with the baseline average pain score (average of daily worst abdominal pain the week prior to randomization), 2) Bristol Stool Scale (BSS) score of 3 or 4 on 66% of reported days in the past week. Abdominal pain was assessed on an 11-point scale where: 0=no pain to 10=worst pain imaginable. Stool consistency was assessed using the BSS 7-point scale where: 1=separate hard lumps, 2=sausage shaped but lumpy, 3=sausage-like with cracks on the surface, 4=sausage-like but smooth and soft, 5=soft blobs with clear cut edges, 6=fluffy pieces with ragged edges, and 7=watery with no solid pieces.
  • Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores at Week 12 [ Time Frame: Baseline (Week prior to Randomization) to Week 12 ]
    Composite responders were defined as participants who completed at least 5 out of 7 days with diary entries during the interval of interest and met both of the following criteria: 1) Average daily pain response scores over the past week improved by ≥30% and at least 2 points as compared with the baseline average pain score (average of daily worst abdominal pain the week prior to randomization), 2) Bristol Stool Scale (BSS) score of 3 or 4 on 66% of reported days in the past week. The participant recorded their abdominal pain in a daily diary using an 11-point scale where: 0=no pain to 10=worst pain imaginable. The participant recorded stool consistency in a daily diary using the BSS 7-point scale where: 1=separate hard lumps, 2=sausage shaped but lumpy, 3=sausage-like with cracks on the surface, 4=sausage-like but smooth and soft, 5=soft blobs with clear cut edges, 6=fluffy pieces with ragged edges, and 7=watery with no solid pieces.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2010)
  • Clinical response to treatment based upon improvement from baseline in both of the following co-primary endpoints: pain intensity as assessed by average daily pain scores; and stool consistency as assessed by Bristol Stool Scores. [ Time Frame: 4 weeks ]
    The patient-reported daily pain score is based on a 0- to 10-point scale, where 0 corresponds to no pain and 10 corresponds to worst imaginable pain. The patient-reported BSS consistency score is based on a 1- to 7-point scale where 1 corresponds to a hard stool and 7 corresponds to watery diarrhea.
  • Clinical response to treatment based upon improvement from baseline in both of the following co-primary endpoints: pain intensity as assessed by average daily pain scores; and stool consistency as assessed by Bristol Stool Scores. [ Time Frame: 8 weeks ]
    The patient-reported daily pain score is based on a 0- to 10-point scale, where 0 corresponds to no pain and 10 corresponds to worst imaginable pain. The patient-reported BSS consistency score is based on a 1- to 7-point scale where 1 corresponds to a hard stool and 7 corresponds to watery diarrhea.
  • Clinical response to treatment based upon improvement from baseline in both of the following co-primary endpoints: pain intensity as assessed by average daily pain scores; and stool consistency as assessed by Bristol Stool Scores. [ Time Frame: 12 weeks ]
    The patient-reported daily pain score is based on a 0- to 10-point scale, where 0 corresponds to no pain and 10 corresponds to worst imaginable pain. The patient-reported BSS consistency score is based on a 1- to 7-point scale where 1 corresponds to a hard stool and 7 corresponds to watery diarrhea.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
  • Change From Baseline in the Weekly Pain Scores [ Time Frame: Baseline (Week Prior to Randomization) to Weeks 4, 8, and 12 ]
    The participant recorded their worst daily pain score in a diary using an 11-point scale where: 0=no pain to 10=worst pain imaginable. The daily scores over the previous week were averaged. A negative change from Baseline indicates improvement.
  • Change From Baseline in Weekly BSS Scores [ Time Frame: Baseline (Week prior to Randomization) to Weeks 4, 8, and 12 ]
    The patient recorded stool consistency in a daily diary using the BSS 7-point scale where: 1=hard stool to 7=watery diarrhea. The daily scores over the previous week were averaged. A negative change from Baseline indicates improvement.
  • Change From Baseline in the Number of Daily Bowel Movements [ Time Frame: Baseline (Week prior to Randomization) to Weeks 4, 8, and 12 ]
    Participants recorded the number of bowel movements in a daily diary at the same time each day. The number of daily bowel movements over the previous week were averaged. A negative change from Baseline indicates improvement.
  • Percentage of Participants With Response Based on Participants Achieving Prespecified Improvement in Symptoms for at Least 50% of the Time [ Time Frame: Baseline (Week Prior to Randomization) to Weeks 1-12 ]
    Responders were participants that met both of the following criteria on the same week for at least 50% of time on study: 1) average of daily pain scores over the past week improved by ≥30% compared with baseline average in pain score, 2) ≥50% reduction in the number of days over the past week with a BSS score ≥5 compared with Baseline. Participants must also have had at least 5/7 days diary entry to be considered a responder for that week. Abdominal pain was assessed on an 11-point scale where a score of 0=no pain to 10=worst pain imaginable. Stool consistency was assessed using the BSS 7-point scale where: 1=separate hard lumps to 7=watery with no solid pieces. Response rates (percentage of participants) are based on model estimates from the logistic regression.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2010)
  • Average daily pain scores [ Time Frame: 4, 8, and 12 weeks ]
  • Stool consistency [ Time Frame: 4, 8, and 12 weeks ]
  • Stool frequency [ Time Frame: 4, 8, and 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea
Brief Summary The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of JNJ-27018966 (eluxadoline) compared with placebo in the treatment of patients with irritable bowel syndrome with diarrhea (IBS-d).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Drug: Eluxadoline
    Tablets, orally, twice daily.
    Other Name: JNJ-27018966
  • Drug: Placebo
    Matching placebo oral tablets twice daily.
Study Arms  ICMJE
  • Experimental: Eluxadoline 5 mg
    Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.
    Intervention: Drug: Eluxadoline
  • Experimental: Eluxadoline 25 mg
    Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. .
    Intervention: Drug: Eluxadoline
  • Experimental: Eluxadoline 100 mg
    Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.
    Intervention: Drug: Eluxadoline
  • Experimental: Eluxadoline 200 mg
    Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.
    Intervention: Drug: Eluxadoline
  • Placebo Comparator: Placebo
    Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2011)
807
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2010)
850
Actual Study Completion Date  ICMJE July 14, 2011
Actual Primary Completion Date July 14, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea
  • Female patients must be:
  • postmenopausal, defined as amenorrhea for at least 2 years at Prescreening,
  • surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
  • abstinent, or
  • if sexually active, be practicing an effective method of birth control.

Key Exclusion Criteria:

  • Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation, mixed IBS, or unsubtyped IBS
  • Patient has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease
  • Patient has a history of diverticulitis within 6 months prior to Prescreening
  • Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of a major vein, or hypercoagulable states.

Other protocol-specific eligibility criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01130272
Other Study ID Numbers  ICMJE 27018966IBS2001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Furiex Pharmaceuticals, Inc
Original Responsible Party June Almenoff, MD, President/Chief Medical Officer, Furiex Pharmaceuticals, Inc
Current Study Sponsor  ICMJE Furiex Pharmaceuticals, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Furiex Pharmaceuticals, Inc
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP