NCT06782594 A Phase Ⅱ Study of Mosapride Citrate Injection in the Treatment of Postoperative Gastrointestinal Dysfunction
| NCT ID | NCT06782594 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shandong New Time Pharmaceutical Co., LTD |
| Condition | Postoperative Gastrointestinal Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-10-18 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2024-10-18 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study.
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.
Contact & Investigator
Guihua Wang, MD
PRINCIPAL INVESTIGATOR
TONGJI HOSPITAL AFFILIATED TO TONGJI MEDICAL COLLEGE HUST
Frequently Asked Questions
Who can join the NCT06782594 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Postoperative Gastrointestinal Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06782594 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06782594 currently recruiting?
Yes, NCT06782594 is actively recruiting participants. Contact the research team at ghwang@tjh.timu.edu.cn for enrollment information.
Where is the NCT06782594 trial being conducted?
This trial is being conducted at Feixian, China, Wuhan, China.
Who is sponsoring the NCT06782594 clinical trial?
NCT06782594 is sponsored by Shandong New Time Pharmaceutical Co., LTD. The principal investigator is Guihua Wang, MD at TONGJI HOSPITAL AFFILIATED TO TONGJI MEDICAL COLLEGE HUST. The trial plans to enroll 150 participants.