Status:
COMPLETED
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery
Lead Sponsor:
IBSA Institut Biochimique SA
Conditions:
Dental Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 moderat...
Eligibility Criteria
Inclusion
- Patients undergoing surgical extraction of a single fully or partially impacted mandibular 3rd molar requiring bone removal.
- Patients experiencing moderate to severe post-operative pain within 6 hours from end of surgery.
- Pre-operative laboratory tests in the reference ranges or without clinically significant abnormalities as judged by the Investigator.
Exclusion
- Surgery performed under general anaesthesia, or sedation.
- Complications occurring during the surgical procedure or in the period before randomisation as judged by the investigator.
- Acute local or systemic infection at the time of surgery that could confound the post-surgical evaluation.
- Patients with clinical signs of gastritis, gastro-duodenal ulcer, GI bleeding. Other GI disturbances or disease that in the opinion of the investigator could be negatively affected by the administration of NSAIDs.
- Clinical signs or history of coagulation disorders that could be negatively affected by NSAIDs administration.
- Hepatic or renal impairment.
- Patients with significant cardiac impairment, history of cerebrovascular disease, history or peripheral arterial disease, uncontrolled hypertension.
- Hypersensitivity to diclofenac or other NSAIDs or to one of the study medication components.
- Patients under chronic treatment with topical or systemic analgesics/NSAIDs.
- Patients under treatment with any medication that may affect the treatment efficacy evaluation.
- Patients under treatment with any medication whose concomitant use may be susceptible to interactions with diclofenac or may affect safety.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00943098
Start Date
September 1 2009
End Date
May 1 2010
Last Update
January 28 2013
Active Locations (3)
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1
The School of Dentistry, University of Birmingham
Birmingham, United Kingdom
2
Department of oral Surgery; University Dental Hospital
Cardiff, United Kingdom
3
The School of Clinical Dentistry, The University of Sheffield
Sheffield, United Kingdom