The Effect of Prucalopride Succinate on Gastrointestinal Motility After Laparoscopic Gastrectomy : Prospective Double Blind Case-control Study

August 16, 2023 updated by: In Gyu Kwon, Gangnam Severance Hospital

In order to improve postoperative ileus in patients undergoing gastrointestinal surgery, digestive medications and prokinetics have been routinely used. Among them, mosapride citrate is widely used as a representative drug, as it is a 5-hydroxytryptamine 4 receptor agonist that increases gastrointestinal motility.

Prucalopride succinate (dihydrobenzofurancarboxamide) is a type of 5-hydroxytryptamine 4 receptor agonist that has a higher affinity for the 5-HT4 receptor compared to mosapride (a benzamide derivative) which belongs to the same class of drugs. Prucalopride succinate has been demonstrated to increase both gastric and colonic motility through in vivo and in vitro studies. As mentioned earlier, it exhibits high specificity for the 5-HT4 receptor. The 5-HT4 receptor is not expressed in the gastric mucosa but is expressed at low concentrations in the small intestine, whereas it is highly expressed in the colonic mucosa. Therefore, prucalopride is widely used as a therapeutic agent for chronic constipation by increasing colonic motility. Furthermore, Prucalopride succinate stimulates the 5-HT4 receptors present in the nerve terminals of the myenteric plexus, promoting the release of acetylcholine. The released acetylcholine acts on α7nAch receptors located on the surface of enteric smooth muscle cells, inhibiting inflammatory responses and reducing postoperative ilues.

A randomized controlled trial (RCT) conducted on 110 patients who underwent gastrointestinal surgery demonstrated that prucalopride succinate showed significant improvement in gastrointestinal motility compared to the control group. Currently, mosapride citrate is widely used as a prokinetic agent in clinical practice. However, preliminary studies have shown no significant efficacy, and when comparing abdominal X-ray images taken on the third day after surgery, there is no significant difference compared to the placebo group. As a result, it can be observed that the recovery of gastrointestinal motility after surgery is not primarily due to small bowel motility but rather delayed gas passing caused by colon motility. Therefore, it can be assumed that using drugs that increase colon motility may be effective in improving gastrointestinal motility after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients over 80 years of age
  2. Ascites or peritoneal metastasis
  3. If you have intestinal obstruction before surgery
  4. If chemotherapy was performed before surgery
  5. If cancer other than gastric cancer is diagnosed
  6. If there is a history of previous major intra-abdominal long-term surgery or abdominal radiation therapy
  7. In case of liver failure or renal failure
  8. Pregnant women
  9. If it is judged that uncontrolled diabetes can affect intestinal function
  10. If you have a stoma

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prucalopride succinate group
Taking prucalopride succinate from the first day to the fifth day after surgery.
Drug: Arm I : Experimental (Prucalopride succinate group)
Experimental group taking prucalopride succinate from day 1 to day 5 after surgery
Placebo Comparator: Control (mosapride citrate) group
Taking mosapride citrate from the first day to the fifth day after surgery.
Drug: Arm II : Control (Mosapride citrate group)
Control gourp taking mosapride citrate from day 1 day 5 after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantitative intestinal motility measurement using radio-opaque markers
Time Frame: Every day from the 1st day to the 5th day after surgery
Every day from the 1st day to the 5th day after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the amount of food intake, first flatus time and first defecation time
Time Frame: Every day from the 1st day to the 5th day after surgery
  1. Quantitatively compare and analyze the amount of food eaten in the test group and the control group.
  2. Compare the first flatus appearance time and first defecation time in the test group and the control group.
Every day from the 1st day to the 5th day 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)

January 25, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2021-0480

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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