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NCT02433847 Clinical Trial

Effect of Mosapride on Gut Transit in Patients With Chronic Constipation or Constipated Irritable Bowel Syndrome and Healthy Subjects

Healthy Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02433847
Other study ID # Mosa_GIFx_1.0
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received April 13, 2015
Last updated April 29, 2015
Start date May 2015
Est. completion date December 2016

Study information
Verified date April 2015
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial Summary

Effect of mosapride 30mg/day on the small bowel and colon transit time in patients with chronic constipation or constipated irritable bowel syndrome.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date December 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Mosapride

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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