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Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea

Primary Purpose

Irritable Bowel Syndrome With Diarrhea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Mesalamine Granules 750 mg
Mesalamine Granules 1500 mg
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Diarrhea focused on measuring IBS, Diarrhea, IBS-D, Irritable Bowel Syndrome, Abdominal pain, Bloating

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Mesalamine Granules 750 mg

Mesalamine Granules 1500 mg

Arm Description

Outcomes

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.
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
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.

Full Information

First Posted
July 30, 2010
Last Updated
November 13, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01177410
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Diarrhea
Keywords
IBS, Diarrhea, IBS-D, Irritable Bowel Syndrome, Abdominal pain, Bloating

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Mesalamine Granules 750 mg
Arm Type
Experimental
Arm Title
Mesalamine Granules 1500 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo capsules once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Mesalamine Granules 750 mg
Intervention Description
750 mg mesalamine granules once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Mesalamine Granules 1500 mg
Intervention Description
1500 mg mesalamine granules once daily for 12 weeks
Primary Outcome Measure Information:
Title
The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Sherwood
State/Province
Arkansas
ZIP/Postal Code
72120
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States

12. IPD Sharing Statement

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Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea

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