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

Primary Purpose

Stomach Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Mosapride citrate

Placebo

About this trial

This is an interventional treatment trial for Stomach Cancer focused on measuring Gastrectomy, Intestinal motility, Mosapride, Adhesion, Ileus

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mosapride group

Placebo group

Arm Description

Patients receive placebo or mosapride citrate (5mg/T) three times a day from the first day after surgery.

Patients receive placebo instead of mosapride citrate (5mg/T) three times a day from the first day after surgery

Outcomes

Primary Outcome Measures

The number of radiopaque markers transferred to the large intestine 3 days after surgery

Intestinal motility after gastrectomy

Secondary Outcome Measures

Full Information

NCT ID

NCT04493125

First Posted

July 28, 2020

Last Updated

July 29, 2020

Sponsor

Gangnam Severance Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04493125

Brief Title

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

Official Title

The Effect of Mosapride Citrate on Gastrointestinal Motility After Gastrectomy:

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 27, 2020 (Anticipated)

Primary Completion Date

September 30, 2021 (Anticipated)

Study Completion Date

September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

"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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Cancer

Keywords

Gastrectomy, Intestinal motility, Mosapride, Adhesion, Ileus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mosapride group

Arm Type

Experimental

Arm Description

Patients receive placebo or mosapride citrate (5mg/T) three times a day from the first day after surgery.

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Patients receive placebo instead of mosapride citrate (5mg/T) three times a day from the first day after surgery

Intervention Type

Drug

Intervention Name(s)

Mosapride citrate

Intervention Description

Patients receive mosapride citrate (5mg/T) three times a day from the first day after surgery.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

The number of radiopaque markers transferred to the large intestine 3 days after surgery

Description

Intestinal motility after gastrectomy

Time Frame

3 Days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients diagnosed with gastric cancer pathologically before surgery Patients who underwent surgical resection (R0 resection) Patients with an ASA score of 3 or less Exclusion Criteria: Patients over 80 years old When there are multiple or peritoneal metastases Intestinal obstruction before surgery When chemotherapy was performed before surgery When cancer other than stomach cancer is diagnosed If you have a long history of major intra-abdominal surgery or a history of abdominal radiotherapy In case of liver failure or kidney failure When it is judged that uncontrolled diabetes may affect intestinal function

12. IPD Sharing Statement

Learn more about this trial

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

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