NCT03108482

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 637 (actual)
• Sponsor: Esteve Pharmaceuticals, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Post-surgical Pain

Interventions

Type	Name	Description
DRUG	Co-crystal E-58425 (Tramadol/Celecoxib)	Co-crystal E-58425 (Tramadol/Celecoxib): Two immediate release oral over-encapsulated tablets of 100 mg, every 12 hours for 48 hours.
DRUG	Tramadol (Ultram®)	Tramadol: One immediate release oral over-encapsulated tablet of 50 mg, every 6 hours for 48 hours.
DRUG	Celecoxib (Celebrex®)	Celecoxib: One immediate release oral over-encapsulated capsule of 100 mg, every 12 hours for 48 hours.
DRUG	Placebo	Placebo 100 mg or 200 mg oral over-encapsulated tablets every 6 hours for 48 hours.

Timeline

• Start date: 2017-03-14
• Primary completion: 2017-11-09
• Completion: 2017-11-28
• First posted: 2017-04-11
• Last updated: 2019-01-24
• Results posted: 2019-01-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study