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

Launched by SHANDONG NEW TIME PHARMACEUTICAL CO., LTD · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Mosapride Citrate Injection for patients who experience gastrointestinal problems after surgery, specifically after elective laparoscopic intestinal surgery. The goal is to see if this medication can help improve gut function and relieve discomfort in patients recovering from these types of surgeries.

To participate in the trial, patients need to be between 18 and 75 years old and should not have certain health issues, such as severe allergies or significant heart and lung problems. Participants will be randomly assigned to receive either the study medication or a placebo (a substance with no active effect) and will be monitored closely throughout the study. This trial is currently recruiting participants, and those interested should discuss their eligibility with their healthcare provider to see if this study might be a good fit for them.

Gender

ALL

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.