What is Mosapride Citrate Injection studying for postoperative gastrointestinal dysfunction?

Mosapride Citrate Injection is being studied to evaluate its effect on improving gastrointestinal function after surgery. This clinical trial aims to determine how the medication influences recovery time for patients undergoing certain intestinal surgeries. The study is sponsored by Shandong New Time Pharmaceutical Co., LTD and uses a randomized, placebo-controlled design.

Who may be eligible for this postoperative gastrointestinal dysfunction clinical trial?

Adults aged 18 to 75 years undergoing elective laparoscopic-assisted intestinal resection between the ileocecal region and sigmoid colon may be eligible. Both genders can participate if they meet health criteria such as normal organ function and no recent history of severe diseases or constipation. Please review eligibility criteria for more details.

Is there any cost to participate in this postoperative gastrointestinal dysfunction clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel arrangements.

Actively Recruiting

Phase 2

Age: 18Years - 75Years

All Genders

ID06782594

Phase II Study Evaluating Mosapride Citrate Injection to Treat Postoperative Gastrointestinal Dysfunction in Adults

Led by Shandong New Time Pharmaceutical Co., LTD · Updated on 2025-01-20

150

Participants Needed

Research Sites

17 weeks

Total Duration

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

Age: 18Years - 75Years

All Genders

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

Research Team

Guihua Wang, MD

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Phase II Study Evaluating Mosapride Citrate Injection to Treat Postoperative Gastrointestinal Dysfunction in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria