At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 746 enrolled
Drug / intervention
Diclofenac +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Controlled Multi-centre Parallel Group Study to Assess the Efficacy and Safety of Multiple Doses of a Topically Applied Combination Containing Diclofenac 2% + Capsaicin 0.075% (2 g Formulation Per Application; 2-times Daily for 5 Days) Compared to Placebo, as Well as to Diclofenac 2% and Capsaicin 0.075% in Patients With Acute Back or Neck Pain
In Brief
A Phase 3 clinical trial evaluating Diclofenac, Capsaicin, and 1 other intervention for Acute Pain. Completed, enrolled 746 participants across 18 sites in 2 countries.
Detailed Summary
This randomised, controlled multi-centre parallel group trial will assess the efficacy and tolerability of a topical formulation gel of the combination of diclofenac and capsaicin in comparison to gels with diclofenac alone, capsaicin alone, and placebo for the treatment of acute back pain or neck pain
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain
CountriesGermany, Russia
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartMay 2016
Primary CompletionJul 2017
Study CompletionJul 2017
TodayJul 2026
First PostedMar 7, 2016
Enrollment StartMay 9, 2016
Primary CompletionJul 13, 2017
Study CompletionJul 21, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.3 years ago
Interventions
Diclofenacdrug
Capsaicindrug
Placebodrug