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

Dental Pain Clinical Trial

Official title:

Efficacy and Safety of a Single s.c. Diclofenac HPBCD 75mg/1ml Injection as Compared to a Single i.m. Voltarol® 75mg/3ml, in the Treatment of Acute Moderate-to-severe Post-surgical Pain Following Dental Surgery (Impacted 3rd Molar Removal).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943098
• Other study ID #: 09PUK-DCsc05
• Status: Completed
• Phase: Phase 3
• First received: July 21, 2009
• Last updated: December 17, 2012
• Start date: September 2009
• Est. completion date: May 2010

Study information

• Verified date: December 2012
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pain

Intervention

Drug:
• Diclofenac HPBCD s.c. 75mg/ml
1 single injection at day of dental surgical extraction
• Voltarol 75mg/3ml i.m.
1 single injection at day of dental surgical extraction

Locations

Country	Name	City	State
United Kingdom	The School of Dentistry, University of Birmingham	Birmingham
United Kingdom	Department of oral Surgery; University Dental Hospital	Cardiff
United Kingdom	The School of Clinical Dentistry, The University of Sheffield	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Difference (PID)	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).	1.5 hours	No
Secondary	PIDs		at 15 minutes post-dose.	No
Secondary	PIDs		at 30 minutes post-dose.	No
Secondary	PIDs		at 45 minutes post-dose.	No
Secondary	PIDs		at 60 minutes post-dose.	No
Secondary	PIDs		at 90 minutes post-dose.	No
Secondary	PIDs		at 2 hours post-dose.	No
Secondary	PIDs		at 3 hours post-dose.	No
Secondary	PIDs		at 4 hours post-dose.	No
Secondary	PIDs		at 5 hours post-dose.	No
Secondary	PIDs		at 6 hours post-dose.	No
Secondary	PIDs		at 7 hours post-dose.	No
Secondary	PIDs		at 8 hours post-dose.	No