Trial Outcomes & Findings for Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea (NCT NCT01177410)
NCT ID: NCT01177410
Last Updated: 2019-11-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
148 participants
Primary outcome timeframe
3 months
Results posted on
2019-11-21
Participant Flow
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
Failure to meet baseline IBS symptom scores (based on diary responses)
Participant milestones
| Measure |
Mesalamine Granules 1500 mg
Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
|
Mesalamine Granules 750 mg
Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
|
Placebo
Placebo : placebo capsules once daily for 12 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
47
|
50
|
|
Overall Study
COMPLETED
|
50
|
40
|
45
|
|
Overall Study
NOT COMPLETED
|
1
|
7
|
5
|
Reasons for withdrawal
| Measure |
Mesalamine Granules 1500 mg
Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
|
Mesalamine Granules 750 mg
Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
|
Placebo
Placebo : placebo capsules once daily for 12 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea
Baseline characteristics by cohort
| Measure |
Mesalamine Granules 1500 mg
n=51 Participants
Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
|
Mesalamine Granules 750 mg
n=47 Participants
Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
|
Placebo
n=50 Participants
Placebo : placebo capsules once daily for 12 weeks
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 13.17 • n=5 Participants
|
44.4 years
STANDARD_DEVIATION 16 • n=7 Participants
|
44.6 years
STANDARD_DEVIATION 12.04 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 13.73 • n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
47 participants
n=7 Participants
|
50 participants
n=5 Participants
|
148 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Mesalamine Granules 1500 mg
n=51 Participants
Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
|
Mesalamine Granules 750 mg
n=47 Participants
Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
|
Placebo
n=50 Participants
Placebo : placebo capsules 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.
0 month
|
18 participants
|
27 participants
|
28 participants
|
|
The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.
1 month
|
9 participants
|
5 participants
|
8 participants
|
|
The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.
2 months
|
13 participants
|
5 participants
|
6 participants
|
|
The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.
3 months
|
11 participants
|
10 participants
|
8 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Mesalamine Granules 1500 mg
n=51 Participants
Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
|
Mesalamine Granules 750 mg
n=47 Participants
Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
|
Placebo
n=50 Participants
Placebo : placebo capsules once daily for 12 weeks
|
|---|---|---|---|
|
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 participants
|
15 participants
|
14 participants
|
Adverse Events
Mesalamine Granules 1500 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Mesalamine Granules 750 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mesalamine Granules 1500 mg
n=51 participants at risk
Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
|
Mesalamine Granules 750 mg
n=47 participants at risk
Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
|
Placebo
n=50 participants at risk
Placebo : placebo capsules once daily for 12 weeks
|
|---|---|---|---|
|
Infections and infestations
Incision Site Abscess
|
0.00%
0/51 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
2.1%
1/47 • Number of events 1 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
0.00%
0/50 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/51 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
2.1%
1/47 • Number of events 1 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
0.00%
0/50 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
Other adverse events
| Measure |
Mesalamine Granules 1500 mg
n=51 participants at risk
Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
|
Mesalamine Granules 750 mg
n=47 participants at risk
Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
|
Placebo
n=50 participants at risk
Placebo : placebo capsules once daily for 12 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
3.9%
2/51 • Number of events 2 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
0.00%
0/47 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
6.0%
3/50 • Number of events 3 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
3/51 • Number of events 3 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
2.1%
1/47 • Number of events 1 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
0.00%
0/50 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
7.8%
4/51 • Number of events 6 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
6.4%
3/47 • Number of events 3 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
4.0%
2/50 • Number of events 3 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
3/51 • Number of events 3 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
4.3%
2/47 • Number of events 2 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
2.0%
1/50 • Number of events 1 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
|
Nervous system disorders
Headache
|
5.9%
3/51 • Number of events 5 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
6.4%
3/47 • Number of events 4 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
2.0%
1/50 • Number of events 1 • Study Duration; Reported adverse events (AEs) include AEs observed over the 48 weeks of treatment.
SAEs will be followed for up to 30 days post treatment
|
Additional Information
Vice President of Clinical Operations
Salix Pharmaceuticals, Inc.
Phone: 919-862-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee INVESTIGATOR shall not publish the results of the Study conducted at the INSTITUTION, unless they (i) obtain the prior written consent of SALIX for the publication; or (ii) withhold any publication for a period of two (2) years following the Completion of the Study by all participating institutions and investigators
- Publication restrictions are in place
Restriction type: OTHER