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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04493125
Other study ID # 3-2020-0175
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 27, 2020
Est. completion date September 30, 2021

Study information

Verified date July 2020
Source Gangnam Severance Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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."


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 104
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gangnam Severance Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary The number of radiopaque markers transferred to the large intestine 3 days after surgery Intestinal motility after gastrectomy 3 Days after surgery
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