Treatment of gastrointestinal issues after surgery using mosapride citrate injection

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

This study is testing if a new injection called mosapride citrate can help people who have gastrointestinal problems after surgery feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shandong New Time Pharmaceutical Co., LTD (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Feixian, Shandong and 1 other locations)
• Trial ID: NCT06782594 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study evaluates the efficacy of mosapride citrate injection in treating postoperative gastrointestinal dysfunction. Participants will undergo a screening period followed by a treatment phase lasting 3-5 days, where they will receive either a high or low dose of mosapride citrate or a placebo. After treatment, subjects will enter a follow-up period lasting 7 days to assess outcomes related to gastrointestinal function.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 undergoing elective laparoscopic-assisted intestinal resection involving the ileocecal region to the sigmoid colon.

Not a fit: Patients with a history of significant drug allergies or severe comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery and gastrointestinal function in patients after surgery.

How similar studies have performed: Other studies have shown promise in using similar approaches for gastrointestinal recovery, but this specific application of mosapride citrate is novel.

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.

Where this trial is running

Feixian, Shandong and 1 other locations

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

Study contacts

• Principal investigator: Guihua Wang, MD — Tongji Hospital Affiliated to Tongji Medical College Hust
• Study coordinator: Guihua Wang, MD

Conditions Postoperative Gastrointestinal Dysfunction