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

NCT06782594 | Recruiting Phase 2 DMC

• 1 other identifier: NTP-MSBL-003
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study.

Conditions

Postoperative Gastrointestinal Dysfunction

Outcome Measures

Primary Outcomes (1)

• The time to first flatus recorded by postoperative patients

  Comparison of the effects of experimental drugs and placebo on the time to first flatus postoperative patients

  up to 3 to 5 days

Study Arms (3)

Mosapride Citrate Injection(low)

EXPERIMENTAL

Mosapride Citrate Injection, iv, 4mg, bid, for 3 to 5 days

Drug: Mosapride Citrate Injection(low)

Mosapride Citrate Injection(high)

EXPERIMENTAL

Mosapride Citrate Injection, iv, 8mg, bid, for 3 to 5 days

Drug: Mosapride Citrate Injection(high)

Placebo

PLACEBO COMPARATOR

Placebo, iv, bid, for 3 to 5 days

Drug: Placebo

Interventions

Mosapride Citrate Injection(high) DRUG

Mosapride Citrate Injection, iv, 8mg, bid, for 3 to 5 days

Mosapride Citrate Injection(high)

Mosapride Citrate Injection(low) DRUG

Mosapride Citrate Injection, iv, 4mg, bid, for 3 to 5 days

Mosapride Citrate Injection(low)

Placebo DRUG

Placebo, iv, bid, for 3 to 5 days

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ）Voluntary participation and signing of informed consent;
• \) Aged ≥18 years and ≤75 years and BMI≤28kg/m2, regardless of gender;
• \) 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;
• \) 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;
• \) Those classified as physical condition 1 to 3 by the American Society of Anesthesiologists (ASA).

You may not qualify if:

• \) Patients with a history of clinically significant drug allergy or known allergy to the study drug ingredients and excipients;
• ）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;
• \) Those with a history of drug abuse in the past 6 months;
• \) Those with a history of constipation in the past 6 months (less than 3 bowel movements per week);
• \) 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;
• \) Patients with inflammatory bowel disease (ulcerative colitis or Crohn's disease) and intestinal adhesions;
• \) Those who have undergone major abdominal surgery (such as gastrectomy, gastric bypass, sleeve gastrectomy, gastric band surgery, Whipple surgery, pancreatectomy, colectomy, hemicolectomy);
• \) QTcF interval: ≥450 milliseconds for men and ≥470 milliseconds for women (the QT interval must be corrected for heart rate using the Fridericia formula \[QTcF\]);
• \) Patients who received chemotherapy within 4 weeks before surgery;
• \) 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);
• \) 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;
• \) 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);
• \) Participated in other clinical trials within 3 months before enrollment;

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Study Sites (2)

Shandong New Time Pharmaceutical Co., LTD

Feixian, Shandong, China

RECRUITING

Tongji Hospital Affiliated to Tongji Medical College Hust

Wuhan, China

RECRUITING

Study Officials

• Guihua Wang, MD

  TONGJI HOSPITAL AFFILIATED TO TONGJI MEDICAL COLLEGE HUST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guihua Wang, MD

CONTACT

027-83663640; ghwang@tjh.timu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 20, 2025
• Study Start: October 18, 2024
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2024-10

Locations

CN (2)