Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d) (Protocol JNJ-27018966IBS3002)
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| ClinicalTrials.gov Identifier: NCT01553747 |
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Recruitment Status :
Completed
First Posted : March 14, 2012
Last Update Posted : May 13, 2015
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Sponsor:
Furiex Pharmaceuticals, Inc
Information provided by (Responsible Party):
Furiex Pharmaceuticals, Inc
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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 compared with placebo in the treatment of patients with diarrhea-predominant irritable bowel syndrome.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Irritable Bowel Syndrome | Drug: JNJ-27018966 Other: Placebo Comparator | Phase 3 |
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) and a 30-week blinded treatment period.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | May 2012 |
| Actual Primary Completion Date : | January 2014 |
| Actual Study Completion Date : | February 2014 |
| Arm | Intervention/treatment |
|---|---|
| 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 |
Other: Placebo Comparator
Oral tablets twice daily |
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 ]
Secondary Outcome Measures :
- Pain response based on improvement from baseline in daily abdominal pain scores. [ Time Frame: Daily pain response determined to evaluate response over 12 weeks ]
- 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 ]
- Abdominal bloating [ Time Frame: Daily over 12 and 26 weeks ]
- Bowel movement frequency [ Time Frame: Daily over 12 and 26 weeks ]
- Urgency episodes [ Time Frame: Daily over 12 and 26 weeks ]
- Incontinence episodes [ Time Frame: Daily over 12 and 26 weeks ]
- Irritable Bowel Syndrome global symptom severity response [ Time Frame: Daily over 12 and 26 weeks ]
- 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 ]
- Durability of treatment based on the composite response in daily stool consistency scores. [ Time Frame: Intervals from Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 1-26 ]
- Durability of treatment based on the 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 ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient is 18 to 80 years old
- Patient has a diagnosis of IBS with a subtype of diarrhea defined by the Rome III criteria.
2. 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)
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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
- 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:
- Patient has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
- Patient has a history of inflammatory or immune-mediated GI disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
- Patient has a history of diverticulitis within 3 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, or impaired intestinal circulation (eg, aortoiliac disease).
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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.
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): NCT01553747
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Sponsors and Collaborators
Furiex Pharmaceuticals, Inc
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Furiex Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT01553747 History of Changes |
| Other Study ID Numbers: |
27018966IBS3002 |
| First Posted: | March 14, 2012 Key Record Dates |
| Last Update Posted: | May 13, 2015 |
| Last Verified: | April 2015 |
Keywords provided by Furiex Pharmaceuticals, Inc:
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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:
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Syndrome Diarrhea Irritable Bowel Syndrome Disease Pathologic Processes Signs and Symptoms, Digestive |
Signs and Symptoms Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |