At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 142 enrolled
Drug / intervention
Diclofenac HPBCD s.c. 75mg/ml +1 moredrug
Likely dose
Diclofenac HPBCD s.c. 75mg/mlfrom 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.
Efficacy and Safety of a Single s.c. Diclofenac HPBCD 75mg/1ml Injection as Compared to a Single i.m. Voltarol® 75mg/3ml, in the Treatment of Acute Moderate-to-severe Post-surgical Pain Following Dental Surgery (Impacted 3rd Molar Removal).
In Brief
A Phase 3 clinical trial evaluating Diclofenac HPBCD s.c. 75mg/ml and Voltarol 75mg/3ml i.m. for Dental Pain. Completed, enrolled 142 participants across 3 sites.
Detailed Summary
The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD 75mg/1ml s.c. with the marketed reference product, Voltarol® 75mg/3ml i.m. in the treatment of acute moderate-to-severe pain after dental impaction surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Pain
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartSep 2009
Primary CompletionMar 2010
Study CompletionMay 2010
TodayJul 2026
First PostedJul 22, 2009
Enrollment StartSep 1, 2009
Primary CompletionMar 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.9 years ago
Interventions
Diclofenac HPBCD s.c. 75mg/mldrug
1 single injection at day of dental surgical extraction
Voltarol 75mg/3ml i.m.drug
1 single injection at day of dental surgical extraction