At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Parallel-group, Multi-center, Active- and Placebo-controlled Trial to Evaluate the Analgesic Efficacy and Safety of Multiple Doses of CG5503 IR for Postoperative Pain Following Bunionectomy
In Brief
A Phase 3 clinical trial evaluating CG5503 IR, Morphine, and 1 other intervention for Bunionectomy and 3 related conditions. Completed, enrolled 291 participants across 6 sites.
Detailed Summary
The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability of CG5503 IR 75mg in subjects following bunionectomy. This trial was performed based on a previously performed double-blind, placebo-controlled, multiple-dose trial in the same indication investigating 3 dose strengths CG5503 IR (50, 75 and 100 mg) published under PMID: 18851776.
Study Details
Timeline
Interventions
75mg IR 4 - 6 hourly Total: 72 hours
Morphine 30 mg IR 4 - 6 hourly Total: 72 hours
Placebo; 4 - 6 hourly; Total: 72 hours