At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 306 enrolled
Drug / intervention
Diclofenac HPBCD +3 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.
Efficacy and Safety Study of Diclofenac HPBCD 25, 50 mg/ml Administered as Single s.c. Dose, in the Treatment of Acute Moderate-to-severe Post-surgical Pain From Dental Surgery (Impacted 3rd Molar Extraction)
In Brief
A Phase 3 clinical trial evaluating Diclofenac HPBCD and Placebo s.c. for Dental Pain. Completed, enrolled 306 participants across 6 sites in 2 countries.
Detailed Summary
The present study is proposed to evaluate the efficacy and safety of single doses of Diclofenac HPBCD subcutaneous (s.c.) (25 mg/1 ml and 50 mg/1 ml) in the treatment of acute moderate-to-severe pain after dental impaction surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Pain
CountriesPoland, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartSep 2009
Primary CompletionJan 2010
Study CompletionApr 2010
TodayJul 2026
First PostedJul 21, 2009
Enrollment StartSep 1, 2009
Primary CompletionJan 1, 2010
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.9 years ago
Interventions
Diclofenac HPBCDdrug
1 single injection at day of dental surgical extraction
Diclofenac HPBCDdrug
1 single injection at day of dental surgical extraction
Diclofenac HPBCDdrug
1 single injection at day of dental surgical extraction
Placebo s.c.other
1 single injection at day of dental surgical extraction