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

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: 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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Eluxadoline Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 807 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 28, 2010
Actual Primary Completion Date : July 14, 2011
Actual Study Completion Date : July 14, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Eluxadoline

Arms and Interventions
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Arm Intervention/treatment
Experimental: Eluxadoline 5 mg
Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.
 Drug: Eluxadoline
Tablets, orally, twice daily.
Other Name: JNJ-27018966
Experimental: Eluxadoline 25 mg
Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks. .
 Drug: Eluxadoline
Tablets, orally, twice daily.
Other Name: JNJ-27018966
Experimental: Eluxadoline 100 mg
Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.
 Drug: Eluxadoline
Tablets, orally, twice daily.
Other Name: JNJ-27018966
Experimental: Eluxadoline 200 mg
Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.
 Drug: Eluxadoline
Tablets, orally, twice daily.
Other Name: JNJ-27018966
Placebo Comparator: Placebo
Eluxadoline placebo matching tablets, orally, twice daily for up to 12 weeks.
 Drug: Placebo
Matching placebo oral tablets twice daily.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130272


Locations
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Sponsors and Collaborators
Furiex Pharmaceuticals, Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Furiex Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01130272    
Other Study ID Numbers: 27018966IBS2001
First Posted: May 25, 2010    Key Record Dates
Results First Posted: October 22, 2019
Last Update Posted: October 22, 2019
Last Verified: September 2019
Keywords provided by Furiex Pharmaceuticals, Inc:
Irritable bowel syndrome with diarrhea
Irritable bowel syndrome
Diarrhea predominant irritable bowel syndrome
Colonic diseases
Colonic diseases, functional
Digestive system disease
 Gastrointestinal disease
Intestinal disease
Colonic pseudo-obstruction
Diarrhea
Signs and Symptoms, Digestive
Additional relevant MeSH terms:
Layout table for MeSH terms
Irritable Bowel Syndrome
Syndrome
Diarrhea
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Eluxadoline
Gastrointestinal Agents