Back to resultsEffect of Mosapride on Gut Transit in Patients With Chronic Constipation or Constipated Irritable Bowel Syndrome and Healthy Subjects
Primary Purpose
Constipated Irritable Bowel Syndrome, Chronic Constipation, Healthy
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Mosapride
Sponsored by
About this trial
This is an interventional treatment trial for Constipated Irritable Bowel Syndrome focused on measuring mosapride
Eligibility Criteria
Inclusion Criteria:
- Functional constipation or constipated irritable bowel syndrome patients according to Rome III criteria
Exclusion Criteria:
- Intolerable or hypersensitive to mosapride
- Known Parkinson's ds
- Cardio- or cerebrovascular disease within 3 months
- Malignancy requiring surgery or chemotherapy or radiation within 5 years
- History of GI surgeries except hernia repair, appendectomy, primary closure due to perforation
- Refractory diabetes mellitus/hypertension/thyroid diseases
- Symptomatic heart failure, renal failure, arrhythmia
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mosapride
Arm Description
Outcomes
Primary Outcome Measures
colonic transit time
the change of colonic transit time after mosapride 30mg/day administration
: whole colonic transit time, rt. colon / lt. colon / rectosigmoid colonic transit time
Secondary Outcome Measures
Full Information
NCT ID
NCT02433847
First Posted
April 13, 2015
Last Updated
April 29, 2015
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02433847
Brief Title
Effect of Mosapride on Gut Transit in Patients With Chronic Constipation or Constipated Irritable Bowel Syndrome and Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
5. Study Description
Brief Summary
Effect of mosapride 30mg/day on the small bowel and colon transit time in patients with chronic constipation or constipated irritable bowel syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipated Irritable Bowel Syndrome, Chronic Constipation, Healthy
Keywords
mosapride
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mosapride
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mosapride
Primary Outcome Measure Information:
Title
colonic transit time
Description
the change of colonic transit time after mosapride 30mg/day administration
: whole colonic transit time, rt. colon / lt. colon / rectosigmoid colonic transit time
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Functional constipation or constipated irritable bowel syndrome patients according to Rome III criteria
Exclusion Criteria:
Intolerable or hypersensitive to mosapride
Known Parkinson's ds
Cardio- or cerebrovascular disease within 3 months
Malignancy requiring surgery or chemotherapy or radiation within 5 years
History of GI surgeries except hernia repair, appendectomy, primary closure due to perforation
Refractory diabetes mellitus/hypertension/thyroid diseases
Symptomatic heart failure, renal failure, arrhythmia
12. IPD Sharing Statement
Learn more about this trial
Effect of Mosapride on Gut Transit in Patients With Chronic Constipation or Constipated Irritable Bowel Syndrome and Healthy Subjects
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