A Phase 2 interventional study of Placebo and Mesalamine Granules 750 mg in Irritable Bowel Syndrome With Diarrhea, sponsored by Bausch Health Americas, Inc.. Completed at 20 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-21.
Sponsored by Bausch Health Americas, Inc. · Phase 2, Interventional, and Treatment
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 148 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Drug: Placebo
Drug: Mesalamine Granules 750 mg
Drug: Mesalamine Granules 1500 mg
placebo capsules once daily for 12 weeks
750 mg mesalamine granules once daily for 12 weeks
1500 mg mesalamine granules once daily for 12 weeks
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.
Time frame: 3 months
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.
Time frame: 3 months
Study Period: 09Aug2010 to 16Aug2011. 20 Study Sites; US Only. Study locations were a variety including: Gastrointestinal, Family Practice, Medical Centers and/or University setting
| Milestone | Mesalamine Granules 1500 mg | Mesalamine Granules 750 mg | Placebo |
|---|---|---|---|
| Started | 51 | 47 | 50 |
| Completed | 50 | 40 | 45 |
| Not completed | 1 | 7 | 5 |
| Withdrew: Adverse event | 0 | 2 | 2 |
| Withdrew: Withdrawal by subject | 1 | 4 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
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.
| participants | Mesalamine Granules 1500 mg | Mesalamine Granules 750 mg | Placebo |
|---|---|---|---|
| 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 | 24 | 15 | 14 |
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.
| participants | Mesalamine Granules 1500 mg | Mesalamine Granules 750 mg | Placebo |
|---|---|---|---|
| 0 month | 18 | 27 | 28 |
| 1 month | 9 | 5 | 8 |
| 2 months | 13 | 5 | 6 |
| 3 months | 11 | 10 | 8 |
Collected over Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mesalamine Granules 1500 mg | — | 0/51 (0%) | 15/51 (29.4%) |
| Mesalamine Granules 750 mg | — | 1/47 (2.1%) | 9/47 (19.1%) |
| Placebo | — | 0/50 (0%) | 7/50 (14%) |
| Event | Mesalamine Granules 1500 mg | Mesalamine Granules 750 mg | Placebo |
|---|---|---|---|
| Incision Site AbscessInfections and infestations | 0/51 | 1/47 | 0/50 |
| Intervertebral disc degenerationMusculoskeletal and connective tissue disorders | 0/51 | 1/47 | 0/50 |
| Event | Mesalamine Granules 1500 mg | Mesalamine Granules 750 mg | Placebo |
|---|---|---|---|
| NauseaGastrointestinal disorders | 4/51 | 3/47 | 2/50 |
| HeadacheNervous system disorders | 3/51 | 3/47 | 1/50 |
| Abdominal distensionGastrointestinal disorders | 2/51 | 0/47 | 3/50 |
| FlatulenceGastrointestinal disorders | 3/51 | 1/47 | 0/50 |
| NasopharyngitisInfections and infestations | 3/51 | 2/47 | 1/50 |
| Age, Categorical(Participants) | Mesalamine Granules 1500 mg | Mesalamine Granules 750 mg | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 1 | 0 | 0 | 1 |
| Between 18 and 65 years | 48 | 41 | 48 | 137 |
| >=65 years | 2 | 6 | 2 | 10 |
| Age, Continuous(years) | Mesalamine Granules 1500 mg | Mesalamine Granules 750 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 42.5 ± 13.17 | 44.4 ± 16 | 44.6 ± 12.04 | 43.8 ± 13.73 |
| Sex: Female, Male(Participants) | Mesalamine Granules 1500 mg | Mesalamine Granules 750 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 32 | 30 | 30 | 92 |
| Male | 19 | 17 | 20 | 56 |
| Region of Enrollment(participants) | Mesalamine Granules 1500 mg | Mesalamine Granules 750 mg | Placebo | Total |
|---|---|---|---|---|
| United States | 51 | 47 | 50 | 148 |
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bausch Health Americas, Inc.