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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:
NCT00943098
First received: July 21, 2009
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Dental Pain
Drug: Diclofenac HPBCD s.c. 75mg/ml
Drug: Voltarol 75mg/3ml i.m.
Phase 3

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

Resource links provided by NLM:


Further study details as provided by IBSA Institut Biochimique SA:

Primary Outcome Measures:
  • Pain Intensity Difference (PID) [ Time Frame: 1.5 hours ] [ Designated as safety issue: No ]
    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:
  • PIDs [ Time Frame: at 15 minutes post-dose. ] [ Designated as safety issue: No ]
  • PIDs [ Time Frame: at 30 minutes post-dose. ] [ Designated as safety issue: No ]
  • PIDs [ Time Frame: at 45 minutes post-dose. ] [ Designated as safety issue: No ]
  • PIDs [ Time Frame: at 60 minutes post-dose. ] [ Designated as safety issue: No ]
  • PIDs [ Time Frame: at 90 minutes post-dose. ] [ Designated as safety issue: No ]
  • PIDs [ Time Frame: at 2 hours post-dose. ] [ Designated as safety issue: No ]
  • PIDs [ Time Frame: at 3 hours post-dose. ] [ Designated as safety issue: No ]
  • PIDs [ Time Frame: at 4 hours post-dose. ] [ Designated as safety issue: No ]
  • PIDs [ Time Frame: at 5 hours post-dose. ] [ Designated as safety issue: No ]
  • PIDs [ Time Frame: at 6 hours post-dose. ] [ Designated as safety issue: No ]
  • PIDs [ Time Frame: at 7 hours post-dose. ] [ Designated as safety issue: No ]
  • PIDs [ Time Frame: at 8 hours post-dose. ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: September 2009
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclofenac HPBCD s.c. 75mg/ml Drug: Diclofenac HPBCD s.c. 75mg/ml
1 single injection at day of dental surgical extraction
Active Comparator: Voltarol 75mg/3ml i.m. Drug: Voltarol 75mg/3ml i.m.
1 single injection at day of dental surgical extraction

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943098

Locations
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, United Kingdom
Sponsors and Collaborators
IBSA Institut Biochimique SA
Investigators
Principal Investigator: Ian Brook, Prof The school of Clinical Dentistry
  More Information

No publications provided

Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT00943098     History of Changes
Other Study ID Numbers: 09PUK-DCsc05
Study First Received: July 21, 2009
Results First Received: November 16, 2012
Last Updated: December 17, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014