NCT00943098

Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery

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).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: IBSA Institut Biochimique SA · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dental Pain

Interventions

Type	Name	Description
DRUG	Diclofenac HPBCD s.c. 75mg/ml	1 single injection at day of dental surgical extraction
DRUG	Voltarol 75mg/3ml i.m.	1 single injection at day of dental surgical extraction

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-03-01
• Completion: 2010-05-01
• First posted: 2009-07-22
• Last updated: 2013-01-28
• Results posted: 2013-01-28

Locations

3 sites across 1 country: United Kingdom