Overview

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

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
IBSA Institut Biochimique SA
Treatments:
Diclofenac
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.