CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 382 enrolled
Drug / intervention
Tapentadol IR +1 moredrug
Likely dose
Tapentadol IR 50 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/NCT00814580
NCT00814580Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Multi-Center, Parallel-Group Study of Tapentadol Immediate Release (IR) Versus Oxycodone IR for the Treatment of Subjects With Acute Post-Operative Pain Following Elective Arthroscopic Shoulder Surgery

Ortho-McNeil Janssen Scientific Affairs, LLC·interventional·Posted Dec 25, 2008·Updated Nov 20, 2012

In Brief

A Phase 3 clinical trial evaluating Tapentadol IR and Oxycodone IR for Postoperative Pain. Completed, enrolled 382 participants.

Detailed Summary

The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
Countries--
CollaboratorsGrünenthal GmbH

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 25, 2008
Enrollment StartDec 1, 2008
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.5 years ago

Interventions

Tapentadol IRdrug

First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1, if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed

Oxycodone IRdrug

First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one hour after the first dose on Day 1, if needed Subsequent doses: one or two capsules (5 mg or 10 mg) every 4 to 6 hours as needed