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

April 29, 2015 updated by: Seoul National University Hospital
Effect of mosapride 30mg/day on the small bowel and colon transit time in patients with chronic constipation or constipated irritable bowel syndrome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: mosapride
Drug: Mosapride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
colonic transit time
Time Frame: 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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ANTICIPATED)

April 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (ESTIMATE)

May 5, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

May 5, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mosa_GIFx_1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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