Irritable Bowel Syndrome With DiarrheaPhase 2NCT01177410

Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea

A Phase 2 study testing Mesalamine Granules 750 mg and Mesalamine Granules 1500 mg in people with Irritable Bowel Syndrome With Diarrhea, run by Bausch Health Americas, Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Irritable Bowel Syndrome With Diarrhea
What is being tested?: Mesalamine Granules 750 mg and Mesalamine Granules 1500 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 148 participants
Where: 20 sitesUnited States
Study dates: Jul 2010to Aug 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Study site
Albuquerque, New Mexico, 87102
Study site
Anaheim, California, 92801
Study site
Ann Arbor, Michigan, 48109
Study site
Boynton Beach, Florida, 33426
Study site
Bristol, Connecticut, 06010
Study site
Greensboro, North Carolina, 27408
Study site
Lynchburg, Virginia, 24502
Study site
Macon, Georgia, 31201
Study site
Mexico, Missouri, 65265
Study site
New York, New York, 10016
Study site
Ogden, Utah, 84405
Study site
Plano, Texas, 75075
Study site
Sacramento, California, 95831
Study site
San Diego, California, 92108
Study site
San Francisco, California, 94115
Study site
Sherwood, Arkansas, 72120
Study site
Shreveport, Louisiana, 71103
Study site
St Louis, Missouri, 63141
Study site
St. Petersburg, Florida, 33709
Study site
Wyoming, Michigan, 49519

Other trials in United States

About this study

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

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.

Conditions: Irritable Bowel Syndrome With Diarrhea
Being tested: Placebo, Mesalamine Granules 750 mg, Mesalamine Granules 1500 mg
Keywords: IBS, Diarrhea, IBS-D, Irritable Bowel Syndrome, Abdominal pain, Bloating
Medical subject headings: Diarrhea, Irritable Bowel Syndrome, Abdominal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
placebo capsules once daily for 12 weeks
Mesalamine Granules 750 mgDrug
750 mg mesalamine granules once daily for 12 weeks
Mesalamine Granules 1500 mgDrug
1500 mg mesalamine granules once daily for 12 weeks

Study groups in NCT01177410
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Mesalamine Granules 750 mg	Experimental	Not described Receives: Drug: Mesalamine Granules 750 mg
Mesalamine Granules 1500 mg	Experimental	Not described Receives: Drug: Mesalamine Granules 1500 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months

Secondary outcomes (1)

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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Aug 2011

First posted9 Aug 2010 (estimated)
Study startJul 2010
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Irritable Bowel Syndrome With DiarrheaStudies of the same condition, open and under way.
More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 148 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01177410
Sponsor's protocol ID: MGIB2051
Status last verified: Nov 2019
First submitted: 30 Jul 2010
Last updated: 21 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
RecruitingPhase 2
A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)
Irritable Bowel Syndrome
Not yet recruitingPhase 2
Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
Patients With Irritable Bowel Syndrome With Diarrhea
Not yet recruiting
Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome
Functional Dyspepsia, Irritable Bowel Syndrome With Diarrhea

All Irritable Bowel Syndrome With Diarrhea trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01177410
Acronym / sponsor ID: MGIB2051
Conditions: Irritable Bowel Syndrome With Diarrhea
Keywords: IBS, Diarrhea, IBS-D, Irritable Bowel Syndrome, Abdominal pain, Bloating
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 148 participants (actual)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 9 Aug 2010 (estimated)
Results: Posted 27 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
Mesalamine Granules 750 mg	Experimental	Drug: Mesalamine Granules 750 mg
Mesalamine Granules 1500 mg	Experimental	Drug: Mesalamine Granules 1500 mg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placeboplacebo capsules once daily for 12 weeks	Drug	Placebo
Mesalamine Granules 750 mg750 mg mesalamine granules once daily for 12 weeks	Drug	Mesalamine Granules 750 mg
Mesalamine Granules 1500 mg1500 mg mesalamine granules once daily for 12 weeks	Drug	Mesalamine Granules 1500 mg

Primary outcome

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
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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 27 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mesalamine Granules 1500 mg	51	50
Mesalamine Granules 750 mg	47	40
Placebo	50	45

Primary outcome: 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. Number. Unit: participants

Measure	Mesalamine Granules 1500 mg n = 51	Mesalamine Granules 750 mg n = 47	Placebo n = 50
0 month	18	27	28
1 month	9	5	8
2 months	13	5	6
3 months	11	10	8

Mesalamine Granules 1500 mg vs Placebo: Odds Ratio (OR): 2.232 (95% CI 1.068 to 4.664), p = 0.0327, Proportional Odds Model
Mesalamine Granules 750 mg vs Placebo: Odds Ratio (OR): 1.148 (95% CI 0.531 to 2.483), p = 0.7260, Proportional Odds Model

Population analysed: Intent to Treat Population included all randomized subjects who ingested at least one dose of study drug. Analysis of study data was based on observed cases, missing data remained missing.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mesalamine Granules 1500 mg	0 of 51 (0%)	15 of 51 (29.4%)	Not reported
Mesalamine Granules 750 mg	1 of 47 (2.1%)	9 of 47 (19.1%)	Not reported
Placebo	0 of 50 (0%)	7 of 50 (14%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Irritable Bowel Syndrome With Diarrhea

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
RecruitingPhase 2
A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)
Irritable Bowel Syndrome
Not yet recruitingPhase 2
Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
Patients With Irritable Bowel Syndrome With Diarrhea
Not yet recruiting
Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome
Functional Dyspepsia, Irritable Bowel Syndrome With Diarrhea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01177410.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.