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

This study has been completed.
Information provided by (Responsible Party):
IBSA Institut Biochimique SA Identifier:
First received: July 21, 2009
Last updated: December 17, 2012
Last verified: December 2012
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]
    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. ]
  • PIDs [ Time Frame: at 30 minutes post-dose. ]
  • PIDs [ Time Frame: at 45 minutes post-dose. ]
  • PIDs [ Time Frame: at 60 minutes post-dose. ]
  • PIDs [ Time Frame: at 90 minutes post-dose. ]
  • PIDs [ Time Frame: at 2 hours post-dose. ]
  • PIDs [ Time Frame: at 3 hours post-dose. ]
  • PIDs [ Time Frame: at 4 hours post-dose. ]
  • PIDs [ Time Frame: at 5 hours post-dose. ]
  • PIDs [ Time Frame: at 6 hours post-dose. ]
  • PIDs [ Time Frame: at 7 hours post-dose. ]
  • PIDs [ Time Frame: at 8 hours post-dose. ]

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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00943098

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
Principal Investigator: Ian Brook, Prof The school of Clinical Dentistry
  More Information

Responsible Party: IBSA Institut Biochimique SA 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

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 25, 2017