Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 7:08 PM
Study NCT ID:
NCT06782594
Status:
RECRUITING
Last Update Posted:
2025-01-20
First Post:
2025-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ⅱ Study of Mosapride Citrate Injection in the Treatment of Postoperative Gastrointestinal Dysfunction
Sponsor:
Shandong New Time Pharmaceutical Co., LTD
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: