A randomized, double-blind, multi-center, placebo-controlled, parallel group study to evaluate the efficacy and safety of an Diclofenac 2% (w/w) cutaneous solution applied twice daily in patients with acute uncomplicated unilateral ankle sprain for a period of 7 consecutive days
Phase of Trial: Phase III
Latest Information Update: 13 Jul 2016
At a glance
- Drugs Diclofenac (Primary)
- Indications Musculoskeletal disorders; Repetitive strain injuries; Sports injuries; Sprains
- Focus Registrational; Therapeutic Use
- Sponsors Nuvo Research
- 13 Jul 2016 According to Nuvo Pharmaceuticals media release, based upon the results of this study which shows the change in Pain on movement (POM) from day 1 to day 5 as non-significant but at day 3 as significant, company plans for a new phase III study in Germany with primary endpoint as change in Pain on movement (POM) from day 1 to day 3.
- 10 Mar 2016 Status changed from recruiting to completed as reported by European Clinical Trials Database record.
- 07 Mar 2016 Results published in Nuvo Pharmaceuticals media release.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History