NCT00942448 - Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

306

Conditions

Dental Pain

Interventions

Diclofenac HPBCDDRUG

1 single injection at day of dental surgical extraction

Diclofenac HPBCDDRUG

1 single injection at day of dental surgical extraction

Diclofenac HPBCDDRUG

1 single injection at day of dental surgical extraction

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (6)

Gabinet Stomatologiczny Bartek

Kobyłka, Poland

Centrum Leczenia Chorób Cywilizacyjnych

Warsaw, Poland

Niepubliczny Zakład Opieki Zdrowotnej

Warsaw, Poland

NZOZ Polimedica

Zgierz, Poland