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

NCT05966246 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-08-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Arm I : Experimental (Prucalopride succinate group)

Experimental group taking prucalopride succinate from day 1 to day 5 after surgery

DRUG

Arm II : Control (Mosapride citrate group)

Control gourp taking mosapride citrate from day 1 day 5 after surgery

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05966246 on ClinicalTrials.gov