NCT06782594

A Phase Ⅱ Study of Mosapride Citrate Injection in the Treatment of Postoperative Gastrointestinal Dysfunction

A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy of Mosapride Citrate Injection in the Treatment of Postoperative Gastrointestinal Dysfunction

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study.

Detailed description

The study was divided into three phases: screening period (within 28 days before surgery), treatment period (3-5 days), and follow-up period (7 days after the last dose). Subjects entered the screening period after signing the informed consent form. Subjects who met the inclusion criteria and those who did not meet the exclusion criteria were randomly assigned to trial group 1, trial group 2, or control group at a random ratio of 1:1:1, and received mosapride citrate injection or placebo, respectively. After the treatment period, the subjects entered the follow-up period after the treatment ended.

Conditions

• Postoperative Gastrointestinal Dysfunction

Interventions

Type	Name	Description
DRUG	Mosapride Citrate Injection(high)	Mosapride Citrate Injection, iv, 8mg, bid, for 3 to 5 days
DRUG	Mosapride Citrate Injection(low)	Mosapride Citrate Injection, iv, 4mg, bid, for 3 to 5 days
DRUG	Placebo	Placebo, iv, bid, for 3 to 5 days

Timeline

• Start date: 2024-10-18
• Primary completion: 2025-06-01
• Completion: 2025-10-01
• First posted: 2025-01-20
• Last updated: 2025-01-20

Locations

2 sites across 1 country: China