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

NCT00942448 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2013-01-28

Study results available
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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

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

Sponsors & Collaborators

  • IBSA Institut Biochimique SA

    lead INDUSTRY

Principal Investigators

  • Thomas Dietrich, Prof · The school of dentistry, University of Birmingham

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
2010-01-31
Completion
2010-04-30

Countries

  • Poland
  • 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 NCT00942448 on ClinicalTrials.gov