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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02433847
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Duration (Months): 19.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Constipated Irritable Bowel Syndrome; Chronic Constipation; Healthy	Drug: Mosapride	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2015
• Anticipated Primary Completion Date: Apr 1, 2016
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mosapride	Drug: Mosapride

Outcome Measures

Primary Outcome Measures

1. colonic transit time [2 weeks]

   the change of colonic transit time after mosapride 30mg/day administration : whole colonic transit time, rt. colon / lt. colon / rectosigmoid colonic transit time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02433847
• Other Study ID Numbers: Mosa_GIFx_1.0
• First Posted: May 5, 2015
• Last Update Posted: May 5, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Seoul National University Hospital: mosapride
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation; Mosapride

Study Results

No Results Posted as of May 5, 2015