Effect of Mosapride Citrate on Gastrointestinal Motility After Laparoscopic Gastrectomy

January 6, 2025 updated by: In Gyu Kwon, Gangnam Severance Hospital

The Effect of Mosapride Citrate on Gastrointestinal Motility After Laparoscopic Gastrectomy: Prospective, Double Blind Placebo-controlled Study

"Mosapride citrate is a 5-hydroxytryptamine 4 receptor agonist, and is widely used as an agent to increase intestinal motility. Mosapride citrate has been demonstrated in in vitro and in vivo studies to increase both gastric and colon motility. In a case-control study of patients undergoing colonectomy, mosapride citrate was found to significantly reduce gas passing and defecation time.

Recently, a study reported that mosapride citrate acts on the α7nACh receptor and, consequently, suppresses the inflammatory response of macrophages, thereby suppressing the mechanism that induces paralysis after surgery.

To date, this study is intended to analyze whether mosapride citrate significantly affects the improvement of bowel movement after surgery after gastrectomy."

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

14 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients diagnosed with gastric cancer pathologically before surgery
  2. Patients who underwent surgical resection (R0 resection)
  3. Patients with an ASA score of 3 or less

Exclusion Criteria:

  1. Patients over 80 years old
  2. When there are multiple or peritoneal metastases
  3. Intestinal obstruction before surgery
  4. When chemotherapy was performed before surgery
  5. When cancer other than stomach cancer is diagnosed
  6. If you have a long history of major intra-abdominal surgery or a history of abdominal radiotherapy
  7. In case of liver failure or kidney failure
  8. When it is judged that uncontrolled diabetes may affect intestinal function

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mosapride group
Patients receive placebo or mosapride citrate (5mg/T) three times a day from the first day after surgery.
Drug: Mosapride citrate
Patients receive mosapride citrate (5mg/T) three times a day from the first day after surgery.
Placebo Comparator: Placebo group
Patients receive placebo instead of mosapride citrate (5mg/T) three times a day from the first day after surgery
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of radiopaque markers transferred to the large intestine 3 days after surgery
Time Frame: 3 Days after surgery
Intestinal motility after gastrectomy
3 Days after surgery

Collaborators and Investigators

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

Sponsor

Gangnam Severance 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 (Actual)

July 27, 2020

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

July 29, 2020

First Posted (Actual)

July 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2020-0175

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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