At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, 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
In Brief
A Phase 3 clinical trial evaluating Tapentadol IR 50 mg, Tapentadol IR 75 mg, and 1 other intervention for Hallux Valgus. Completed, enrolled 60 participants across 3 sites.
Detailed Summary
The purpose of this study is to evaluate the analgesic efficacy and safety of tapentadol immediate-release (IR \[CG5503\]) for use in the relief of moderate to severe acute pain, compared with placebo, in adult Taiwanese patients with acute pain following bunionectomy.
Study Details
Timeline
Interventions
Tapentadol IR 50 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.
Tapentadol IR 75 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.
Placebo will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.