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Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d) (Protocol JNJ-27018966IBS3001)

This study is currently recruiting participants.
Verified May 2013 by Furiex Pharmaceuticals, Inc
Sponsor:
Information provided by (Responsible Party):
Furiex Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01553591
First received: March 8, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  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 diarrhea-predominant irritable bowel syndrome.


Condition Intervention Phase
Irritable Bowel Syndrome
 Drug: JNJ-27018966
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Furiex Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Composite response based on improvements from baseline in daily abdominal pain and daily stool consistency scores. [ Time Frame: Daily response determined to evaluate composite response over 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain response based on improvement from baseline in daily abdominal pain scores [ Time Frame: Daily pain response determined to evaluate response rates over 12 weeks ] [ Designated as safety issue: No ]
  • Stool consistency response based on improvement from baseline in daily stool consistency scores. [ Time Frame: Daily stool consistency response determined to evaluate response over 12 weeks ] [ Designated as safety issue: No ]
  • Abdominal bloating [ Time Frame: Daily over 12 and 26 weeks ] [ Designated as safety issue: No ]
  • Bowel movement frequency [ Time Frame: Daily over 12 and 26 weeks ] [ Designated as safety issue: No ]
  • Urgency episodes [ Time Frame: Daily over 12 and 26 weeks ] [ Designated as safety issue: No ]
  • Incontinence episodes [ Time Frame: Daily over 12 and 26 weeks ] [ Designated as safety issue: No ]
  • Irritable Bowel Syndrome global symptom severity response [ Time Frame: Daily over 12 and 26 weeks ] [ Designated as safety issue: No ]
  • Durability of treatment based on composite response in daily abdominal pain scores. [ Time Frame: Intervals from Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 1-26 ] [ Designated as safety issue: No ]
  • Durability of treatment based on composite response in daily stool consistency scores. [ Time Frame: Intervals from Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 1-26 ] [ Designated as safety issue: No ]
  • Durability of treatment based on composite response in Irritable Bowel Syndrome Global symptom severity. [ Time Frame: Intervals from Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 1-12, Weeks 1-26 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1125
Study Start Date: May 2012
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JNJ-27018966 75 mg twice daily Drug: JNJ-27018966
Oral tablets twice daily
Experimental: JNJ-27018966 100 mg twice dialy Drug: JNJ-27018966
Oral tablets twice daily
Placebo Comparator: Matching placebo twice daily Drug: Placebo
Oral tablets twice daily

Detailed Description:

The study will consist of a pretreatment phase (consisting of an up to 1-week prescreening period and an up to 3-week screening period), a 52-week double-blind treatment phase and a 2-week post-treatment follow-up period.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is 18 to 80 years old
  2. Patient has a diagnosis of IBS with a subtype of diarrhea defined by the Rome III criteria.

  3. Patient has had a colonoscopy performed:

    • Within 10 years prior to Prescreening if patient is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or CT colonography within the past 5 years is acceptable)

    • Since the onset (if applicable) of any of the following alarm features for patients of any age:

      • Patient has documented weight loss within the past 6 months
      • Patient has nocturnal symptoms
      • Patient has a familial history of first-degree relatives with colon cancer or
      • Patient has blood mixed with their stool (excluding blood from hemorrhoids).

  4. Female patients must be:

    • Postmenopausal, defined as 52 years or older and amenorrheic 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.

Exclusion Criteria:

  1. Patient has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
  2. Patient has a history of inflammatory or immune-mediated GI disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
  3. Patient has a history of diverticulitis within 3 months prior to Prescreening.
  4. Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).

  5. Patient has any of the following surgical history:

    • Cholecystectomy with any history of post cholecystectomy biliary tract pain
    • Any abdominal surgery within the 3 months prior to Prescreening
    • Patient has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)

Other protocol-specific eligibility criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553591

Contacts
Contact: PPD Patient Recruitment Services 1-877-345-2145

  Show 330 Study Locations
Sponsors and Collaborators
Furiex Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Furiex Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01553591     History of Changes
Other Study ID Numbers: 27018966IBS3001
Study First Received: March 8, 2012
Last Updated: May 7, 2013
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 May 16, 2013