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

IBSA

Status and phase: Completed; Phase 3

Conditions: Dental Pain

Treatments: Other: Placebo s.c.; Drug: Diclofenac HPBCD

Study type: Interventional

Funder types: Industry

Identifiers

NCT00942448

09PUK-DCsc04

Details and patient eligibility

About

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.

Enrollment: 306 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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306 participants in 4 patient groups, including a placebo group

Diclofenac HPBCD s.c. 25mg/ml

Experimental group

Treatment:

Drug: Diclofenac HPBCD

Drug: Diclofenac HPBCD

Drug: Diclofenac HPBCD

Diclofenac HPBCD s.c. 50mg/ml

Experimental group

Treatment:

Drug: Diclofenac HPBCD

Drug: Diclofenac HPBCD

Drug: Diclofenac HPBCD

Diclofenac HPBCD s.c. 75mg/ml

Active Comparator group

Treatment:

Drug: Diclofenac HPBCD

Drug: Diclofenac HPBCD

Drug: Diclofenac HPBCD

Placebo s.c. (1ml)

Placebo Comparator group

Treatment:

Other: Placebo s.c.