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

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

Overview

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.

Interventions

• 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

Primary outcome measures

• The time to first flatus recorded by postoperative patients [Time frame: up to 3 to 5 days]

Eligibility criteria

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 pseudo-obstruction), poorly controlled Those with diabetes (HbA1c>8.5%) or gastrointestinal pacemakers installed in their bodies;

6\) Patients with inflammatory bowel disease (ulcerative colitis or Crohn's disease) and intestinal adhesions;

7\) Those who have undergone major abdominal surgery (such as gastrectomy, gastric bypass, sleeve gastrectomy, gastric band surgery, Whipple surgery, pancreatectomy, colectomy, hemicolectomy);

8\) QTcF interval: ≥450 milliseconds for men and ≥470 milliseconds for women (the QT interval must be corrected for heart rate using the Fridericia formula \[QTcF\]);

9\) Patients who received chemotherapy within 4 weeks before surgery;

10\) Those who are scheduled for emergency surgery or undergo any of the following surgeries: appendectomy, low anterior resection, colostomy, ileostomy, or stoma reversal, or diagnosed with needing proctocolectomy/low anterior resection Subjects whose disease may cause impaired rectal function or postoperative incontinence (except for lesions that do not involve the sigmoid colon and above);

11\) Within 3 days before the first dose, patients had received stimulants such as alvimopan, erythromycin, prucalopride, metoclopramide, domperidone, cisapride, mosapride, renzapride or azithromycin. Gastrointestinal motility drugs;

12\) Pregnant or lactating women, as well as those who plan to become pregnant or donate sperm or eggs during the study period and within 3 months after the end of the study, and are unwilling to use a medically recognized contraceptive measure (such as intrauterine contraceptive device or contraceptive) during the study period. sets);

13\) Participated in other clinical trials within 3 months before enrollment;

14\) Other subjects deemed unsuitable for inclusion by the researcher.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 2 centers

• Shandong New Time Pharmaceutical Co., LTD — Feixian
• Tongji Hospital Affiliated to Tongji Medical College Hust — Wuhan

Identifiers

NCT: NCT06782594 · NTP-MSBL-003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗