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

IBSA

Status and phase

Completed

Phase 3

Conditions

Dental Pain

Treatments

Drug: Diclofenac HPBCD s.c. 75mg/ml

Drug: Voltarol 75mg/3ml i.m.

Study type

Interventional

Funder types

Industry

Identifiers

NCT00943098

09PUK-DCsc05

Details and patient eligibility

About

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.

Enrollment

142 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.