CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 136 enrolled
Drug / intervention
buprenorphine +1 moredrug
Likely dose
tramadol/acetaminophen 325 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01983111
NCT01983111Phase 4Completed
CompareCT.gov

A Multicenter, Phase IV, Interventional Study to Compare the Efficacy and Safety of NORSPAN to Tramadol/Acetaminophen in Patients With Prolonged Postoperative Pain After Spinal Surgery (PASSION)

Mundipharma Korea Ltd·interventional·Posted Nov 13, 2013·Updated Jul 11, 2016

In Brief

A Phase 4 clinical trial evaluating buprenorphine and tramadol/acetaminophen for Pain. Completed, enrolled 136 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 13, 2013
Enrollment StartOct 1, 2013
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.6 years ago

Interventions

buprenorphinedrug

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

tramadol/acetaminophendrug

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.