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

NCT00943098 | Completed Phase 3 Results

• 1 other identifier: 09PUK-DCsc05
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 3

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.

Conditions

Dental Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• PIDs

  at 15 minutes post-dose.

• PIDs

  at 30 minutes post-dose.

• PIDs

  at 45 minutes post-dose.

• PIDs

  at 60 minutes post-dose.

• PIDs

  at 90 minutes post-dose.

Study Arms (2)

Diclofenac HPBCD s.c. 75mg/ml

EXPERIMENTAL

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

Voltarol 75mg/3ml i.m.

ACTIVE COMPARATOR

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

Interventions

Diclofenac HPBCD s.c. 75mg/ml DRUG

1 single injection at day of dental surgical extraction

Diclofenac HPBCD s.c. 75mg/ml

Voltarol 75mg/3ml i.m. DRUG

1 single injection at day of dental surgical extraction

Voltarol 75mg/3ml i.m.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (3)

The School of Dentistry, University of Birmingham

Birmingham, United Kingdom

Location

Department of oral Surgery; University Dental Hospital

Cardiff, United Kingdom

Location

The School of Clinical Dentistry, The University of Sheffield

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Toothache

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Barbara Gugliotta, Clincial Research Manager
• Organization: IBSA Institut Biochimique

barbara.gugliotta@ibsa.ch

+41 58 360 10 00

Study Officials

• Ian Brook, Prof

  The school of Clinical Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 22, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 28, 2013
• Results First Posted: January 28, 2013

Record last verified: 2012-12

Locations

GB (3)