Effect of Mosapride on Gut Transit in Patients With Chronic Constipation or Constipated Irritable Bowel Syndrome and Healthy Subjects
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 5, 2015
April 1, 2015
11 months
April 13, 2015
April 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 weeks
Study Arms (1)
mosapride
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Functional constipation or constipated irritable bowel syndrome patients according to Rome III criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2015
First Posted
May 5, 2015
Study Start
May 1, 2015
Primary Completion
April 1, 2016
Study Completion
December 1, 2016
Last Updated
May 5, 2015
Record last verified: 2015-04