A Phase Ⅱ Study of Mosapride Citrate Injection in the Treatment of Postoperative Gastrointestinal… (NCT06782594) | Clinical Trial Compass
RecruitingPhase 2
A Phase â…¡ Study of Mosapride Citrate Injection in the Treatment of Postoperative Gastrointestinal Dysfunction
China150 participantsStarted 2024-10-18
Plain-language summary
This study is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
1)Voluntary participation and signing of informed consent;
2\) Aged ≥18 years and ≤75 years and BMI≤28kg/m2, regardless of gender;
3\) Patients undergoing elective laparoscopic-assisted intestinal resection and the surgical site is part of the intestinal segment from the ileocecal region to the sigmoid colon;
4\) Vital organ functions meet the following requirements:iver function:
ALT and AST≤3×ULN, total bilirubin level≤2×ULN;
Renal function: serum creatinine (Cr)≤1.5×ULN or creatinine clearance≥50mL/min (when Cr\>1.5×ULN);
Blood routine examination: hemoglobin (HGB)≥80g/L;
Blood biochemistry: albumin (ALB)≥30g/L;
5\) Those classified as physical condition 1 to 3 by the American Society of Anesthesiologists (ASA).
Exclusion Criteria:
1\) Patients with a history of clinically significant drug allergy or known allergy to the study drug ingredients and excipients;
2)Those who have a history of severe heart, lung, liver, kidney, blood, endocrine, immune, skin, neurological or mental diseases in the past two years or currently have diseases of the above systems;
3\) Those with a history of drug abuse in the past 6 months;
4\) Those with a history of constipation in the past 6 months (less than 3 bowel movements per week);
5\) Severe mechanical intestinal obstruction that is not expected to be relieved after surgery, short bowel syndrome, significant gastrointestinal motility disorders (such as gastroparesis, scleroderma, chronic intestinal pseud…
What they're measuring
1
The time to first flatus recorded by postoperative patients