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Study of Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)for Treatment of Post Operative Nausea and Vomiting

NCT01984931 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2013-11-15

No results posted yet for this study

Summary

This study will determine if giving Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)orally will be effective as a prophylactic anti-emetic drug for patients who underwent arthroscopic rotator cuff repair under general anesthesia.

Conditions

Interventions

DRUG

Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)

Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)is a noncompetitive spasmolytic agent. It possesses moderate opiate receptor affinity and has marked anti-serotonin activity especially on'M' receptors. A single dose of NEWBUTIN SR 300 mg Tab orally will be given one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively.

DRUG

Metoclopramide hydrochloride monohydrate

Sponsors & Collaborators

  • Korea United Pharm. Inc.

    collaborator INDUSTRY

  • CM Chungmu Hospital

    lead OTHER

Principal Investigators

  • Paolo Alan B Tabar, MD · International Education Center of Shoulder, Elbow Surgery: Chungmu Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01984931 on ClinicalTrials.gov