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Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)

NCT01983111 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2016-07-11

Study results available
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Summary

The purpose of this study is to compare the efficacy and safety of buprenorphine transdermal system to tramadol/acetaminophen.

Conditions

Interventions

DRUG

buprenorphine

Dosage and administration: This one patch should be attached every 7 days.

DRUG

tramadol/acetaminophen

Amount of drug ingredients : Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug. Dosage and administration: Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets.

Sponsors & Collaborators

  • Mundipharma Korea Ltd

    lead INDUSTRY

Principal Investigators

  • Jinhyok Kim, Dr.PhD · Sanggye Paik Hospital, Dept. of Orthopedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-11-30
Completion
2014-11-30

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 NCT01983111 on ClinicalTrials.gov