Clinical trial NCT01177410: Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome With Diarrhea
Keywords: IBS
Diarrhea
IBS-D
Irritable Bowel Syndrome
Abdominal pain
Bloating
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-09
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.
timeFrame: 3 months
Secondary outcomes:
measure: 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
timeFrame: 3 months
Other outcomes:
Locations:
city: Sherwood
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Bristol
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Macon
country: United States
state: Georgia
city: Shreveport
country: United States
state: Louisiana
city: Ann Arbor
country: United States
state: Michigan
city: Wyoming
country: United States
state: Michigan
city: Mexico
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Plano
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: Lynchburg
country: United States
state: Virginia
Study officials:
References: