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

ConditionPostoperative Gastrointestinal Dysfunction

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShandong New Time Pharmaceutical Co., LTD

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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
Placebo
Drug
Placebo, iv, bid, for 3 to 5 days

Treatment groups

150 Participants

are divided into 3 treatment groups

Group A: Mosapride Citrate Injection(low)Experimental treatment 1 intervention

Group B: Mosapride Citrate Injection(high)Experimental treatment 1 intervention

Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

up to 3 to 5 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong New Time Pharmaceutical Co., LTD

Lead sponsor

Source ClinicalTrials.gov

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