Trial Outcomes & Findings for The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study (NCT NCT01412372)
NCT ID: NCT01412372
Last Updated: 2020-12-31
Results Overview
BSS score measured from sum of BSS items of abdominal pain severity, bloating severity, diarrhea severity, constipation severity, and how satisfied are you with bowel habits, and measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
61 participants
Primary outcome timeframe
Baseline and 8 weeks
Results posted on
2020-12-31
Participant Flow
Participant milestones
| Measure |
Placebo
This arm will include those who are randomized to the placebo
Placebo: This is an inactive pill
|
Mesalamine
This arm is for subjects randomized to the study drug, Mesalamine
Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
26
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Baseline characteristics by cohort
| Measure |
Placebo
n=30 Participants
This arm will include those who are randomized to the placebo
Placebo: This is an inactive pill
|
Mesalamine
n=31 Participants
This arm is for subjects randomized to the study drug, Mesalamine
Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 13 • n=5 Participants
|
40 years
STANDARD_DEVIATION 12 • n=7 Participants
|
43 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Not all study participants provided complete outcome results at baseline and 8 weeks. For change in overall BSS, only 25 placebo participants and 28 mesalamine participants provided data for analysis.
BSS score measured from sum of BSS items of abdominal pain severity, bloating severity, diarrhea severity, constipation severity, and how satisfied are you with bowel habits, and measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Outcome measures
| Measure |
Placebo
n=25 Participants
This arm will include those who are randomized to the placebo
Placebo: This is an inactive pill
|
Mesalamine
n=28 Participants
This arm is for subjects randomized to the study drug, Mesalamine
Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
|
|---|---|---|
|
Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period
|
-4 score on a scale
Standard Error 3
|
-13 score on a scale
Standard Error 3
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Not all study participants provided complete outcome results at baseline and 8 weeks. For change in average overall IBS specific Quality of Life, only 25 placebo participants and 28 mesalamine participants provided data for analysis.
As measured by the IBS specific Quality of Life questionnaire which consists of 34 items scored on a scale of 0% to 100%, 0 being not at all and 100 being extremely.
Outcome measures
| Measure |
Placebo
n=25 Participants
This arm will include those who are randomized to the placebo
Placebo: This is an inactive pill
|
Mesalamine
n=28 Participants
This arm is for subjects randomized to the study drug, Mesalamine
Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
|
|---|---|---|
|
Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period.
|
4 score on a scale
Standard Error 4
|
8 score on a scale
Standard Error 4
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksMeasured by the participant reported average number of daily bowel movements.
Outcome measures
| Measure |
Placebo
n=26 Participants
This arm will include those who are randomized to the placebo
Placebo: This is an inactive pill
|
Mesalamine
n=28 Participants
This arm is for subjects randomized to the study drug, Mesalamine
Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
|
|---|---|---|
|
Change in Average Bowel Frequency After 8-Week Treatment Period
|
0.0 Bowel movements per day
Standard Error 0.5
|
-0.9 Bowel movements per day
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Not all study participants provided complete outcome results at baseline and 8 weeks. For change in average bowel consistency, only 26 placebo participants and 26 mesalamine participants provided data for analysis.
Measured using the Bristol Stool form scale 1-7, with 1 being the most formed and 7 the least formed.
Outcome measures
| Measure |
Placebo
n=26 Participants
This arm will include those who are randomized to the placebo
Placebo: This is an inactive pill
|
Mesalamine
n=26 Participants
This arm is for subjects randomized to the study drug, Mesalamine
Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
|
|---|---|---|
|
Change in Average Bowel Consistency Score After an 8 Week Treatment Period.
|
-0.5 score on a scale
Standard Error 0.2
|
-0.8 score on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksMeasured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Outcome measures
| Measure |
Placebo
n=26 Participants
This arm will include those who are randomized to the placebo
Placebo: This is an inactive pill
|
Mesalamine
n=28 Participants
This arm is for subjects randomized to the study drug, Mesalamine
Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
|
|---|---|---|
|
Change in Average Abdominal Pain Score After an 8 Week Treatment Period
|
-5 score on a scale
Standard Error 6
|
-9 score on a scale
Standard Error 4
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Not all study participants provided complete outcome results at baseline and 8 weeks. For change in average bloating, only 25 placebo participants and 28 mesalamine participants provided data for analysis.
Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Outcome measures
| Measure |
Placebo
n=25 Participants
This arm will include those who are randomized to the placebo
Placebo: This is an inactive pill
|
Mesalamine
n=28 Participants
This arm is for subjects randomized to the study drug, Mesalamine
Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
|
|---|---|---|
|
Change in Average Bloating Score After an 8 Week Treatment Period.
|
-4 score on a scale
Standard Error 4
|
-8 score on a scale
Standard Error 6
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Mesalamine
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=30 participants at risk
This arm will include those who are randomized to the placebo
Placebo: This is an inactive pill
|
Mesalamine
n=31 participants at risk
This arm is for subjects randomized to the study drug, Mesalamine
Mesalamine: 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
3.3%
1/30 • Number of events 1 • 8 weeks
|
6.5%
2/31 • Number of events 2 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/30 • 8 weeks
|
3.2%
1/31 • Number of events 1 • 8 weeks
|
|
Ear and labyrinth disorders
Motion Sickness
|
0.00%
0/30 • 8 weeks
|
3.2%
1/31 • Number of events 1 • 8 weeks
|
|
General disorders
light headed/dizziness
|
0.00%
0/30 • 8 weeks
|
9.7%
3/31 • Number of events 3 • 8 weeks
|
|
Gastrointestinal disorders
Bloating
|
3.3%
1/30 • Number of events 1 • 8 weeks
|
3.2%
1/31 • Number of events 1 • 8 weeks
|
|
General disorders
Swelling
|
0.00%
0/30 • 8 weeks
|
3.2%
1/31 • Number of events 1 • 8 weeks
|
|
Metabolism and nutrition disorders
Weight Gain
|
0.00%
0/30 • 8 weeks
|
3.2%
1/31 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
|
General disorders
Fatigue
|
0.00%
0/30 • 8 weeks
|
3.2%
1/31 • Number of events 1 • 8 weeks
|
|
General disorders
Fever
|
0.00%
0/30 • 8 weeks
|
3.2%
1/31 • Number of events 1 • 8 weeks
|
|
General disorders
Sharp pain
|
0.00%
0/30 • 8 weeks
|
3.2%
1/31 • Number of events 1 • 8 weeks
|
|
General disorders
Abdominal Pain
|
3.3%
1/30 • Number of events 1 • 8 weeks
|
6.5%
2/31 • Number of events 2 • 8 weeks
|
|
Gastrointestinal disorders
Increased bowel movement
|
0.00%
0/30 • 8 weeks
|
6.5%
2/31 • Number of events 2 • 8 weeks
|
|
General disorders
Nausea
|
3.3%
1/30 • Number of events 1 • 8 weeks
|
3.2%
1/31 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Heartburn
|
3.3%
1/30 • Number of events 1 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
|
Hepatobiliary disorders
Elevated Liver Function Tests
|
3.3%
1/30 • Number of events 1 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
|
General disorders
Chest Pain
|
3.3%
1/30 • Number of events 1 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
|
Gastrointestinal disorders
Gas
|
6.7%
2/30 • Number of events 2 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
|
Gastrointestinal disorders
Reflux
|
3.3%
1/30 • Number of events 1 • 8 weeks
|
3.2%
1/31 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/30 • 8 weeks
|
3.2%
1/31 • Number of events 1 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place