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History of Changes for Study: NCT01553747
Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome (Protocol JNJ-27018966IBS3002)
Latest version (submitted July 27, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 13, 2012 None (earliest Version on record)
2 May 8, 2012 Study Status and Contacts/Locations
3 May 30, 2012 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 June 12, 2012 Contacts/Locations, Outcome Measures, Study Status and Eligibility
5 June 20, 2012 Contacts/Locations, Study Description and Study Status
6 July 18, 2012 Contacts/Locations and Study Status
7 September 20, 2012 Contacts/Locations and Study Status
8 October 18, 2012 Study Status and Contacts/Locations
9 October 29, 2012 Contacts/Locations and Study Status
10 October 30, 2012 Contacts/Locations and Study Status
11 November 19, 2012 Contacts/Locations, Study Status, Eligibility and Study Identification
12 January 7, 2013 Contacts/Locations and Study Status
13 February 26, 2013 Contacts/Locations and Study Status
14 April 12, 2013 Study Status and Contacts/Locations
15 May 7, 2013 Contacts/Locations and Study Status
16 June 18, 2013 Recruitment Status, Contacts/Locations and Study Status
17 February 4, 2014 Recruitment Status, Contacts/Locations, Study Status and Study Design
18 March 25, 2014 Study Status
19 April 26, 2015 Contacts/Locations, Study Status
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Results Submission Events
20 July 27, 2018 Study Status, Outcome Measures, Arms and Interventions, More Information, Study Description, Study Identification, Adverse Events, Baseline Characteristics, Participant Flow, Contacts/Locations, Eligibility and Study Design
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Study NCT01553747
Submitted Date:  March 13, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: 27018966IBS3002
Brief Title: Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome (Protocol JNJ-27018966IBS3002)
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2012
Overall Status: Not yet recruiting
Study Start: March 2012
Primary Completion: January 2013 [Anticipated]
Study Completion:
First Submitted: March 8, 2012
First Submitted that
Met QC Criteria:
March 13, 2012
First Posted: March 14, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 13, 2012
Last Update Posted: March 14, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Furiex Pharmaceuticals, Inc
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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.
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 26-week double-blind treatment phase and a 4-week blinded withdrawal period.
Open or close this module Conditions
Conditions: Irritable Bowel Syndrome
Keywords: 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
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 1125 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: JNJ-270189966 75 mg twice daily Drug: JNJ-27018966
Oral tablets twice daily
Experimental: JNJ-27018966 100 mg twice daily Drug: JNJ-27018966
Oral tablets twice daily
Placebo Comparator: Matching placebo twice daily
Placebo Comparator
Oral tablets twice daily
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Composite response based on improvements from baseline in daily abdominal pain scores.
[ Time Frame: Daily response determined to evaluate composite response over 12 weeks ]

2. Composite response based on improvements from baseline in daily stool consistency scores.
[ Time Frame: Daily response determined to evaluate composite response over 12 weeks ]

Secondary Outcome Measures:
1. 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 ]

2. 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 ]

3. Abdominal bloating
[ Time Frame: Daily for 12 weeks ]

4. Bowel movement frequency
[ Time Frame: Daily for 12 weeks ]

5. Urgency episodes
[ Time Frame: Daily for 12 weeks ]

6. Incontinence episodes
[ Time Frame: Daily for 12 weeks ]

7. Irritable Bowel Syndrome global symptom severity
[ Time Frame: Daily for 12 weeks ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Patient has a diagnosis of IBS with a subtype of diarrhea defined by the Rome III criteria.
  2. Patients of at least 50 years of age has had a colonoscopy performed within 5 years or if the patient has any of the following alarm features
    • Patient has documented weight loss within the past 5 months
    • Patient has nocturnal symptoms
    • Patient has a familial history of colon cancer
    • Patient has blood mixed with their stool (excluding blood from hemorrhoids).
  3. 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.

Open or close this module Contacts/Locations
Central Contact Person: PPD Patient Recruitment Services
Telephone: 1-877-345-2145
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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