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

Phase 3

Completed

• Conditions: Dental Pain
• Interventions: Drug: Diclofenac HPBCD s.c. 75mg/ml; Drug: Voltarol 75mg/3ml i.m.

• Registration Number: NCT00943098
• Lead Sponsor: IBSA Institut Biochimique SA

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 moderate-to-severe pain after dental impaction surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-22
• Study Start: 2009-09
• Primary Completion: 2010-03
• Study Completion: 2010-05
• Results First Submitted: 2012-11-16
• Status Verified: 2012-12
• Results First Submitted QC: 2012-12-17
• Last Update Submitted: 2012-12-17
• Results First Posted: 2013-01-28
• Last Update Posted: 2013-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diclofenac HPBCD s.c. 75mg/ml	Diclofenac HPBCD s.c. 75mg/ml	-
Voltarol 75mg/3ml i.m.	Voltarol 75mg/3ml i.m.	-

Primary Outcome Measures

Name	Time	Method
Pain Intensity Difference (PID)	1.5 hours	Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

Secondary Outcome Measures

Name	Time	Method
PIDs	at 8 hours post-dose.

Trial Locations

Locations (3)

The School of Clinical Dentistry, The University of Sheffield; 🇬🇧 Sheffield, United Kingdom

The School of Dentistry, University of Birmingham; 🇬🇧 Birmingham, United Kingdom

Department of oral Surgery; University Dental Hospital; 🇬🇧 Cardiff, United Kingdom