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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Furiex Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01130272
First received: May 24, 2010
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of JNJ-27018966 compared with placebo in the treatment of patients with irritable bowel syndrome with diarrhea (IBS-d).


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: JNJ-27018966
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Furiex Pharmaceuticals, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Average daily pain scores [ Time Frame: 4, 8, and 12 weeks ] [ Designated as safety issue: No ]
  • Stool consistency [ Time Frame: 4, 8, and 12 weeks ] [ Designated as safety issue: No ]
  • Stool frequency [ Time Frame: 4, 8, and 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 807
Study Start Date: May 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JNJ-27018966 5 mg twice daily Drug: JNJ-27018966
oral tablets
Experimental: JNJ-27018966 25 mg twice daily Drug: JNJ-27018966
oral tablets
Experimental: JNJ-27018966 100 mg twice daily Drug: JNJ-27018966
oral tablets
Experimental: JNJ-27018966 200 mg twice daily Drug: JNJ-27018966
oral tablets
Placebo Comparator: Placebo
Matching placebo oral tablets twice daily
Drug: Placebo
Matching placebo oral tablets twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130272

  Show 292 Study Locations
Sponsors and Collaborators
Furiex Pharmaceuticals, Inc
  More Information

No publications provided by Furiex Pharmaceuticals, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Furiex Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01130272     History of Changes
Other Study ID Numbers: 27018966IBS2001
Study First Received: May 24, 2010
Last Updated: June 11, 2012
Health Authority: United States: Food and Drug Administration

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:
Diarrhea
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014