Postoperative Gastrointestinal DysfunctionPhase 2NCT06782594
A Phase Ⅱ Study of Mosapride Citrate Injection in the Treatment of Postoperative Gastrointestinal Dysfunction
A Phase 2 study testing Mosapride Citrate Injection(high) and Mosapride Citrate Injection(low) in people with Postoperative Gastrointestinal Dysfunction, run by Shandong New Time Pharmaceutical Co., LTD at 2 sites in China.
Trial summary
This study is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Gastrointestinal Dysfunction
- What is being tested?
- Mosapride Citrate Injection(high) and Mosapride Citrate Injection(low)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 18 Oct 2024to Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Show all 9Show fewer
- 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).
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Shandong New Time Pharmaceutical Co., LTD
Feixian, Shandong
Jianxiang Zhang, 0539-8330397, jianxiangzhang@126.com
- Recruiting
Tongji Hospital Affiliated to Tongji Medical College Hust
Wuhan
Guihua Wang, ghwang@tjh.timu.edu.cn
About this study
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
This study is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study.
Read the 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.
- Being tested
- Mosapride Citrate Injection(high), Mosapride Citrate Injection(low), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mosapride Citrate Injection(high)Drug
Mosapride Citrate Injection, iv, 8mg, bid, for 3 to 5 days
Mosapride Citrate Injection(low)Drug
Mosapride Citrate Injection, iv, 4mg, bid, for 3 to 5 days
PlaceboDrug
Placebo, iv, bid, for 3 to 5 days
| Study group | Role | What they receive |
|---|---|---|
| Mosapride Citrate Injection(low) | Experimental | Mosapride Citrate Injection, iv, 4mg, bid, for 3 to 5 days Receives: Drug: Mosapride Citrate Injection(low) |
| Mosapride Citrate Injection(high) | Experimental | Mosapride Citrate Injection, iv, 8mg, bid, for 3 to 5 days Receives: Drug: Mosapride Citrate Injection(high) |
| Placebo | Placebo comparator | Placebo, iv, bid, for 3 to 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 3 to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start18 Oct 2024
- Primary completionJun 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guihua Wang, MD, Principal investigator, TONGJI HOSPITAL AFFILIATED TO TONGJI MEDICAL COLLEGE HUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782594
- Sponsor's protocol ID
- NTP-MSBL-003
- Status last verified
- Oct 2024
- First submitted
- 8 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06782594
- Acronym / sponsor ID
- NTP-MSBL-003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mosapride Citrate Injection(low) | Experimental | Drug: Mosapride Citrate Injection(low)Mosapride Citrate Injection, iv, 4mg, bid, for 3 to 5 days |
| Mosapride Citrate Injection(high) | Experimental | Drug: Mosapride Citrate Injection(high)Mosapride Citrate Injection, iv, 8mg, bid, for 3 to 5 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, iv, bid, for 3 to 5 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
- 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);
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mosapride Citrate Injection(high)Mosapride Citrate Injection, iv, 8mg, bid, for 3 to 5 days | Drug | Mosapride Citrate Injection(high) |
| Mosapride Citrate Injection(low)Mosapride Citrate Injection, iv, 4mg, bid, for 3 to 5 days | Drug | Mosapride Citrate Injection(low) |
| PlaceboPlacebo, iv, bid, for 3 to 5 days | Drug | Placebo |
Primary outcome
The time to first flatus recorded by postoperative patients
Time frame: up to 3 to 5 days
Comparison of the effects of experimental drugs and placebo on the time to first flatus postoperative patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
Related trials for Postoperative Gastrointestinal Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Different Acupoint Stimulation for Postoperative Gastrointestinal Dysfunction in Primary Liver Cancer Patients
Primary Liver Cancer
Not yet recruiting
Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery
Postoperative Gastric Distension, Postoperative Gastrointestinal Dysfunction
Recruiting
the Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Gastrointestinal Dysfunction After Urological Laparoscopic Surgery
Postoperative Gastrointestinal Dysfunction (POGD)
Recruiting
Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia
Low Anterior Resection Syndrome (LARS), Rectal Neoplasm Malignant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guihua Wang, MD principal investigator
TONGJI HOSPITAL AFFILIATED TO TONGJI MEDICAL COLLEGE HUST
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mosapride Citrate Injection(high) and Mosapride Citrate Injection(low) in people with Postoperative Gastrointestinal Dysfunction, run by Shandong New Time Pharmaceutical Co., LTD at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guihua Wang, MD (027-83663640, ghwang@tjh.timu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to first flatus recorded by postoperative patients (time frame: up to 3 to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.