Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea
This study has been completed.
Sponsor:
Salix Pharmaceuticals
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01177410
First received: July 30, 2010
Last updated: August 28, 2012
Last verified: August 2012
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Purpose
The purpose of this study is to determine the daily dose of mesalamine granules that will provide adequate relief from symptoms of IBS with diarrhea.
| Condition | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome With Diarrhea |
Drug: Placebo Drug: Mesalamine Granules 750 mg Drug: Mesalamine Granules 1500 mg |
Phase 2 |
| 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 Phase II, Randomized, Placebo-controlled, Double-blind, Multicenter, 12 Week Study to Assess the Efficacy and Safety of Mesalamine Granules 750 mg and 1,500 mg Capsules Administered Once Daily in the Treatment of Irritable Bowel Syndrome With Diarrhea |
Resource links provided by NLM:
Further study details as provided by Salix Pharmaceuticals:
Primary Outcome Measures:
- The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months. [ Time Frame: 3 months ] [ Designated as safety issue: No ]A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.
Secondary Outcome Measures:
- Proportion of Subjects Who Are Monthly Responders in Both Abdominal Pain and Stool Consistency for at Least 2 Months During the 3-month Treatment Period [ Time Frame: 3 months ] [ Designated as safety issue: No ]A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.
| Enrollment: | 148 |
| Study Start Date: | July 2010 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
placebo capsules once daily for 12 weeks
|
| Experimental: Mesalamine Granules 750 mg |
Drug: Mesalamine Granules 750 mg
750 mg mesalamine granules once daily for 12 weeks
|
| Experimental: Mesalamine Granules 1500 mg |
Drug: Mesalamine Granules 1500 mg
1500 mg mesalamine granules once daily for 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Male or non-pregnant, non-lactating female subjects Diagnosed with IBS confirmed by the Rome III criteria
Meet the following IBS symptom scores in all categories during the diary eligibility period:
- An average daily score of greater than or equal to 3 for abdominal pain
- An average daily score of greater than or equal to 3 for bloating
- An average daily score of 5 or greater for stool consistency using the Bristol Stool Scale
- Does not have adequate relief of IBS symptoms (weekly reported) over the past 7 days on the first day of screening and on the day of randomization
Exclusion Criteria:
- Present with hard or lumpy stools (Type 1 or Type 2) on the Bristol Stool form Scale during the diary eligibility period
- history of inflammatory bowel disease
- has Type 1 or 2 diabetes
- pregnant or lactating
- history of HIV or hepatitis B or C
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177410
Locations
| United States, Arkansas | |
| Sherwood, Arkansas, United States, 72120 | |
| United States, California | |
| Anaheim, California, United States, 92801 | |
| Sacramento, California, United States, 95831 | |
| San Diego, California, United States, 92108 | |
| San Francisco, California, United States, 94115 | |
| United States, Connecticut | |
| Bristol, Connecticut, United States, 06010 | |
| United States, Florida | |
| Boynton Beach, Florida, United States, 33426 | |
| St. Petersburg, Florida, United States, 33709 | |
| United States, Georgia | |
| Macon, Georgia, United States, 31201 | |
| United States, Louisiana | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| Wyoming, Michigan, United States, 49519 | |
| United States, Missouri | |
| Mexico, Missouri, United States, 65265 | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Greensboro, North Carolina, United States, 27408 | |
| United States, Texas | |
| Plano, Texas, United States, 75075 | |
| United States, Utah | |
| Ogden, Utah, United States, 84405 | |
| United States, Virginia | |
| Lynchburg, Virginia, United States, 24502 | |
Sponsors and Collaborators
Salix Pharmaceuticals
More Information
No publications provided
| Responsible Party: | Salix Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01177410 History of Changes |
| Other Study ID Numbers: | MGIB2051 |
| Study First Received: | July 30, 2010 |
| Results First Received: | August 21, 2012 |
| Last Updated: | August 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Salix Pharmaceuticals:
|
IBS Diarrhea IBS-D |
Irritable Bowel Syndrome Abdominal pain Bloating |
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 Mesalamine Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013