Actively Recruiting
A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Study to Evaluate Mosapride Citrate Injection for Postoperative Gastrointestinal Dysfunction
Led by Shandong New Time Pharmaceutical Co., LTD · Updated on 2025-01-20
150
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of Mosapride Citrate Injection in treating postoperative gastrointestinal dysfunction. The study is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical trial involving adult patients undergoing certain types of intestinal surgery. It seeks to understand how this treatment influences recovery after surgery, focusing on gastrointestinal function. Participants are randomly assigned to one of three groups: one receiving a low dose of Mosapride Citrate Injection (4 mg), another receiving a high dose (8 mg), and a placebo group. Each treatment is given intravenously twice daily for 3 to 5 days. The study has three phases: a screening period up to 28 days before surgery, a treatment period lasting 3 to 5 days after surgery, and a follow-up period of 7 days after the last dose. During the study, participants will be monitored for the time it takes to first pass gas after surgery, which indicates gastrointestinal recovery. Assessments include medical evaluations during screening, treatment monitoring, and follow-up visits. Safety and response to the medication are tracked throughout the study, which concludes approximately 7 days after treatment ends.
CONDITIONS
Brief Title
A Phase Ⅱ Study of Mosapride Citrate Injection in the Treatment of Postoperative Gastrointestinal Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Aged 18 to 75 years with BMI up to 28 kg/m2, any gender
- Undergoing elective laparoscopic-assisted intestinal resection involving the intestinal segment from the ileocecal region to the sigmoid colon
- Normal liver function (ALT and AST ≤3×ULN, total bilirubin ≤2×ULN)
- Normal renal function (serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min if serum creatinine >1.5×ULN)
- Hemoglobin ≥80 g/L
- Albumin ≥30 g/L
- Classified as physical condition 1 to 3 by the American Society of Anesthesiologists (ASA)
You will not qualify if you...
- History of significant drug allergy or allergy to study drug ingredients
- History or current severe diseases of heart, lung, liver, kidney, blood, endocrine, immune, skin, neurological, or mental systems within the past two years
- History of drug abuse in the past 6 months
- History of constipation in the past 6 months (less than 3 bowel movements per week)
- Severe mechanical intestinal obstruction unlikely to be relieved by surgery, short bowel syndrome, significant gastrointestinal motility disorders, poorly controlled diabetes (HbA1c >8.5%), or gastrointestinal pacemaker
- Inflammatory bowel disease (ulcerative colitis or Crohn's disease) and intestinal adhesions
- Previous major abdominal surgery such as gastrectomy or colectomy
- QTcF interval ≥450 milliseconds for men and ≥470 milliseconds for women
- Chemotherapy within 4 weeks before surgery
- Scheduled emergency surgery or surgeries affecting rectal function or causing postoperative incontinence
- Use of gastrointestinal motility stimulants within 3 days before first dose
- Pregnant or lactating women, those planning pregnancy or donating sperm/eggs during the study and 3 months after, unwilling to use contraception
- Participation in other clinical trials within 3 months before enrollment
- Other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 4 weeks before surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 5 days
Participants receive Mosapride Citrate Injection or placebo intravenously twice daily for 3 to 5 days after surgery to treat postoperative gastrointestinal dysfunction.
Daily visits for 3 to 5 days
Duration - 7 days
Participants are monitored for safety and recovery for 7 days after the last dose of treatment.
1 to 2 visits during follow-up
Trial Site Locations
Total: 2 locations
1
Shandong New Time Pharmaceutical Co., LTD
Feixian, Shandong, China
Actively Recruiting
2
Tongji Hospital Affiliated to Tongji Medical College Hust
Wuhan, China
Actively Recruiting
Research Team
G
Guihua Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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