At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Active- (Tramadol and Celecoxib) and Placebo-controlled, Parallel Groups, Phase 3 Clinical Trial to Establish the Efficacy of Co-crystal E-58425 for the Management of Moderate to Severe Post-surgical Pain After Bunionectomy.
In Brief
A Phase 3 clinical trial evaluating Co-crystal E-58425 (Tramadol/Celecoxib), Tramadol (Ultram®), and 2 other interventions for Acute Post-surgical Pain. Completed, enrolled 637 participants across 5 sites.
Detailed Summary
This is a Phase 3, randomized, double-blind, controlled, parallel-group, multicenter clinical trial with co-crystal E-58425 compared to tramadol, to celecoxib, and to placebo. The primary objective of the trial is to establish the analgesic efficacy of co-crystal E-58425 by demonstrating a superior effect compared to tramadol and to celecoxib for the management of moderate to severe acute post-operative pain for 48 hours after bunionectomy.
Study Details
Timeline
Interventions
Co-crystal E-58425 (Tramadol/Celecoxib): Two immediate release oral over-encapsulated tablets of 100 mg, every 12 hours for 48 hours.
Tramadol: One immediate release oral over-encapsulated tablet of 50 mg, every 6 hours for 48 hours.
Celecoxib: One immediate release oral over-encapsulated capsule of 100 mg, every 12 hours for 48 hours.
Placebo 100 mg or 200 mg oral over-encapsulated tablets every 6 hours for 48 hours.