Phase 3Completed
Co-crystal E-58425 vs Tramadol and Celecoxib for Moderate to Severe Acute Pain After Bunionectomy. Phase III Clinical Trial.
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.
- Sponsor
- Esteve Pharmaceuticals, S.A. (Industry)
- Enrolment
- 637 enrolled
- Conditions
- Acute Post-surgical Pain
- Interventions
- Co-crystal E-58425 (Tramadol/Celecoxib); Tramadol (Ultram®); Celecoxib (Celebrex®); Placebo
- Ages
- adults, older adults
- Registry
- NCT03108482
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Sum of Pain Intensity Differences (SPID)
History
Last registry update
Results first posted
Study completion
Primary completion
Registered
Started