At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 177 enrolled
Drug / intervention
Tapentadol +1 moredrug
Likely dose
Tapentadol 30 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.
A Randomized, Double-blind, Placebo-controlled Parallel Group, Multicenter Trial to Evaluate the Efficacy and Safety of Multiple Dose Administration of an Intravenous Formulation of Tapentadol in the Treatment of Acute Pain Following Bunionectomy.
In Brief
A Phase 2 clinical trial evaluating Tapentadol and Matching Placebo for Bunion and Pain. Completed, enrolled 177 participants across 1 site.
Detailed Summary
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.
Study Details
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2011
First PostedSep 2011
Primary CompletionFeb 2012
TodayJul 2026
First PostedSep 16, 2011
Enrollment StartSep 1, 2011
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.8 years ago
Interventions
Tapentadoldrug
30 mg per administration, maximum 12 administrations over 48 hours
Matching Placebodrug
Maximum 12 administrations over 48 hours