Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:
NCT00942448
First received: July 17, 2009
Last updated: December 17, 2012
Last verified: February 2011
  Purpose

The present study is proposed to evaluate the efficacy and safety of single doses of Diclofenac HPBCD subcutaneous (s.c.) (25 mg/1 ml and 50 mg/1 ml) in the treatment of acute moderate-to-severe pain after dental impaction surgery.


Condition Intervention Phase
Dental Pain
Drug: Diclofenac HPBCD
Other: Placebo s.c.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Diclofenac HPBCD 25, 50 mg/ml Administered as Single s.c. Dose, in the Treatment of Acute Moderate-to-severe Post-surgical Pain From Dental Surgery (Impacted 3rd Molar Extraction)

Resource links provided by NLM:


Further study details as provided by IBSA Institut Biochimique SA:

Primary Outcome Measures:
  • Pain Intensity Difference (PID) on a 0-100 VAS [ Time Frame: at 1.5 hours after treatment administration ] [ 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 assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).


Secondary Outcome Measures:
  • PID [ Time Frame: at 15 minutes post-dose. ] [ 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 assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

  • PID [ Time Frame: at 30 minutes post-dose. ] [ 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 assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

  • PID [ Time Frame: at 45 minutes post-dose. ] [ 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 assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

  • PID [ Time Frame: at 60 minutes post-dose. ] [ 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 assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

  • PID [ Time Frame: at 90 minutes post-dose. ] [ 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 assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

  • PID [ Time Frame: at 2 hours post-dose. ] [ 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 assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

  • PID [ Time Frame: at 3 hours post-dose. ] [ 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 assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

  • PID [ Time Frame: at 4 hours post-dose. ] [ 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 assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

  • PID [ Time Frame: at 5 hours post-dose. ] [ 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 assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

  • PID [ Time Frame: at 6 hours post-dose. ] [ 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 assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

  • PID [ Time Frame: at 7 hours post-dose. ] [ 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 assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

  • PID [ Time Frame: at 8 hours post-dose. ] [ 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 assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).


Enrollment: 306
Study Start Date: September 2009
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclofenac HPBCD s.c. 25mg/ml Drug: Diclofenac HPBCD
1 single injection at day of dental surgical extraction
Experimental: Diclofenac HPBCD s.c. 50mg/ml Drug: Diclofenac HPBCD
1 single injection at day of dental surgical extraction
Active Comparator: Diclofenac HPBCD s.c. 75mg/ml Drug: Diclofenac HPBCD
1 single injection at day of dental surgical extraction
Placebo Comparator: Placebo s.c. (1ml) Other: Placebo s.c.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942448

Locations
Poland
Gabinet Stomatologiczny Bartek
Kobyłka, Poland, 05-230
Centrum Leczenia Chorób Cywilizacyjnych
Warszawa, Poland, 02-797
Niepubliczny Zakład Opieki Zdrowotnej
Warszawa, Poland, 03-252
NZOZ Polimedica
Zgierz, Poland, 95-100
United Kingdom
The School of Dentistry; University of Birmingham
Birmingham, United Kingdom, B4 6NN
Eastman Dental Institute, University College London
London, United Kingdom, WC1X8LD
Sponsors and Collaborators
IBSA Institut Biochimique SA
Investigators
Principal Investigator: Thomas Dietrich, Prof The school of dentistry, University of Birmingham
  More Information

No publications provided

Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT00942448     History of Changes
Other Study ID Numbers: 09PUK-DCsc04
Study First Received: July 17, 2009
Results First Received: November 16, 2012
Last Updated: December 17, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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 September 14, 2014