Overview

Co-crystal E-58425 vs Tramadol and Celecoxib for Moderate to Severe Acute Pain After Bunionectomy. Phase III Clinical Trial.

Status:
Completed

Trial end date:
2017-11-28

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Laboratorios del Dr. Esteve, S.A.

Collaborator:

Premier Research Group plc

Treatments:

Celecoxib
Methamphetamine
Tramadol