CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 667 enrolled
Drug / intervention
NUCYNTA +1 moredrug
Likely dose
NUCYNTA 100 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/NCT00986180
NCT00986180Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Parallel-Group Study of NUCYNTA (Tapentadol) Immediate Release vs. Oxycodone Immediate Release for the Treatment of Acute Low Back Pain

Ortho-McNeil Janssen Scientific Affairs, LLC·interventional·Posted Sep 29, 2009·Updated Dec 19, 2012

In Brief

A Phase 3 clinical trial evaluating NUCYNTA and Oxycodone IR for Pain and 3 related conditions. Completed, enrolled 667 participants across 74 sites.

Detailed Summary

Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Back Pain, Low Back Pain, Back Pain With Radiation
CountriesUnited States
CollaboratorsGrünenthal GmbH

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 29, 2009
Enrollment StartSep 1, 2009
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.8 years ago

Interventions

NUCYNTAdrug

50, 75, or 100 mg every 4 to 6 hours for up to 10 days as needed for pain

Oxycodone IRdrug

5, 10, or 15 mg every 4 to 6 hours for up to 10 days as needed for pain