NCT00942448

Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: IBSA Institut Biochimique SA · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dental Pain

Interventions

Type	Name	Description
DRUG	Diclofenac HPBCD	1 single injection at day of dental surgical extraction
DRUG	Diclofenac HPBCD	1 single injection at day of dental surgical extraction
DRUG	Diclofenac HPBCD	1 single injection at day of dental surgical extraction
OTHER	Placebo s.c.	1 single injection at day of dental surgical extraction

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-01-01
• Completion: 2010-04-01
• First posted: 2009-07-21
• Last updated: 2013-01-28
• Results posted: 2013-01-28

Locations

6 sites across 2 countries: Poland, United Kingdom