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

NCT00943098 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2013-01-28

Study results available
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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

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

Sponsors & Collaborators

  • IBSA Institut Biochimique SA

    lead INDUSTRY

Principal Investigators

  • Ian Brook, Prof · The school of Clinical Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00943098 on ClinicalTrials.gov