At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 901 enrolled
Drug / intervention
Tapentadol (CG5503) +3 moredrug
Likely dose
Tapentadol (CG5503) 50mgfrom 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.
A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Tapentadol Immediate-Release Formulation in the Treatment of Acute Pain From Bunionectomy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Feb 13, 2008·Updated May 9, 2014
In Brief
A Phase 3 clinical trial evaluating Tapentadol (CG5503), oxycodone, and 1 other intervention for Arthralgia and 3 related conditions. Completed, enrolled 901 participants across 7 sites.
Detailed Summary
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have had a bunionectomy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthralgia, Bunion, Hallux Valgus, Pain
CountriesUnited States
CollaboratorsGrünenthal GmbH
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedFeb 2008
Primary CompletionOct 2008
TodayJul 2026
First PostedFeb 13, 2008
Enrollment StartFeb 1, 2008
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.4 years ago
Interventions
Tapentadol (CG5503)drug
50mg capsule q4-6 hrs for 3 days
Tapentadol (CG5503)drug
75mg capsule q4-6 hrs for 3 days
oxycodonedrug
10mg capsule q4-6 hrs for 3 days
placebodrug
1 capsule q4-6 hrs for 3 days