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

NCT01984931 | Unknown Phase 3 DMC

• 1 other identifier: CMH-2013-02
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Nausea; Vomiting

Keywords

post operative nausea and vomiting; Trimebutine Maleate

Outcome Measures

Primary Outcomes (1)

• Severity of nausea after taking Trimebutine Maleate as a prophylactic medication

  The severity of nausea will be graded on a four-point scale. 0- no nausea (can do all tasks). 1- mild nausea (can talk and answer questions appropriately,sit, stand but can't walk). 2- moderate nausea (can talk and but answer questions inappropriately, sit but can't stand and walk). 3- severe nausea (don't talk and answer questions, prefers lying down, cannot sit, stand and walk).

  0-48 hours post rotator cuff repair

Secondary Outcomes (1)

• Frequency of PONV after taking Trimebutine Maleate as a prophylactic medication

  0-48 hours post rotator cuff repair

Study Arms (2)

Trimebutine Maleate 300 mg Tab

EXPERIMENTAL

A single dose of NEWBUTIN SR 300 mg Tab will be given orally one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively.

Drug: Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)

Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A

ACTIVE COMPARATOR

Anti-emetic medication protocol of Chungmu Hospital includes MACPERAN (Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A)thru IV twice in a day

Drug: Metoclopramide hydrochloride monohydrate

Interventions

Trimebutine Maleate (NEWBUTIN SR 300 mg Tab) DRUG

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.

Also known as: •Antinime, •Cineprac, •Colixane B (Trimebutine and Bromazepam), •Colixane Prokin (Trimebutine and Mosapride), •Colixane, •Colonix B (Trimebutine and Bromazepam), •Colonix, •Colospasmyl, •Colperin, •Crobutin, •Debricol, •Debridat, •Débridat, •Eumotrix, •Ibuproct (Trimebutine and Ruscogenin), •Ibutin, •Libertrim, •Libertrim Pediátrico (pediatric), •Libertrim SDP (Trimebutine and Simeticone), •Libertrim SII (Trimebutine and Simeticone), •Muvett, •Polybutine, •Prescol, •Proctolog (Trimebutine and Ruscogenin), •Promebutin, •Ruscolog (Trimebutine and Ruscogenin), •Tribux, •Trimebutin, •Trimebutina Genfar, •Trimebutina La Santé, •Trimebutina, •Trimebutino Andromaco, •Trimedine, •Trimegam, •Trimet, •Altrip, •Apo-Trimebutine, •Biorgan B (Trimebutine and Bromazepam), •Biorgan, •Bumetin, •Butikinon, •Cerekinon, •Cerenamelin, •Colobutine, •Colypan, •Debretin, •Debricalm, •Debridat AP, •Debridat B (Trimebutine and Bromazepam), •Debridat Fort, •Debrum (Trimebutine and Medazepam), •Derispan, •Digerent, •Diway, •Dolpic, •Eumotil, •Eumotil-S (Trimebutine and Simeticone), •Eumotil-T (Trimebutine and Bromazepam), •Eutransil, •Fenatrop, •Garapepsin, •Gaspat, •Gismotal, •Liement, •Mebucolon, •Mebutit, •Miopropan, •Modulon, •Mustrick, •Muvett S (Trimebutine and Simeticone), •Newbutin SR, •Ni Wei Fu, •Pelkysil, •Pilemain, •Polibutin, •Recutin, •Rekelat, •Rui Jian, •Sakion, •Selumito, •Shuang Di, •Spabutine, •Spamoin, •Supeslone, •Sutent, •Tarabutine, •Tefmetin, •Tidomel, •Timotor, •Transacalm, •Tribudat Forte, •Tribudat, •Tributin, •Tricin, •Tridat, •Trienter, •Trim, •Trimebutin Maleate Taiyo, •Trimebutina Angenerico, •Trimebutina Colmed, •Trimebutina maleato, •Trimebutina MK, •Trimébutine Actavis, •Trimébutine Almus, •Trimébutine ALS, •Trimébutine Arrow, •Trimébutine Biogaran, •Trimébutine CristerS, •Trimébutine EG, •Trimébutine Evolugen, •Trimébutine Isomed, •Trimébutine maléate RPG, •Trimébutine Mylan, •Trimébutine Pfizer, •Trimébutine Qualimed, •Trimébutine Ranbaxy, •Trimébutine Ratio, •Trimébutine Ratiopharm, •Trimébutine Sandoz, •Trimébutine Teva, •Trimébutine Zentiva, •Trimébutine Zydus, •Trimebutino Maleato, •Trimedat, •Trishi, •VeM, •Yuan Sheng Li Wei

Trimebutine Maleate 300 mg Tab

Metoclopramide hydrochloride monohydrate DRUG

Metoclopramide hydrochloride monohydrate 8.46 mg/2ml/A

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• post arthroscopic cuff repair patient previously diagnosed with small to large rotator cuff tear thru MRI

You may not qualify if:

• above 70 years old
• massive rotator cuff tear

Sponsors & Collaborators

• CM Chungmu Hospital: lead
• Korea United Pharm. Inc.: collaborator

Study Sites (1)

Chungmu General Hopsital

Seoul, Yeongdeungpo-gu, 150-034, South Korea

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Trimebutine; Bromazepam; mosapride; ruscogenin; Simethicone; lidaprim; Medazepam; Sunitinib; tricin; Metoclopramide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxybenzoate Ethers; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Indoles; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Chlorobenzoates

Study Officials

• Paolo Alan B Tabar, MD

  International Education Center of Shoulder, Elbow Surgery: Chungmu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Hoon Lhee, MD, PhD

CONTACT

+82 (2) 2068/4525; cmirb@naver.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of CM Chungmu Hospital

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 15, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 15, 2013

Record last verified: 2013-11

Locations

KR (1)