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

Dental Pain Clinical Trial

Official title:
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).

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00943098
Study type Interventional
Source IBSA Institut Biochimique SA
Contact
Status Completed
Phase Phase 3
Start date September 2009
Completion date May 2010
View Details
See also
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