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

July 17, 2009
December 17, 2012
September 2009
January 2010   (final data collection date for primary outcome measure)
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).
pain intensity difference (PID) on a 0-100 VAS [ Time Frame: at 1.5 hours after treatment administration ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00942448 on ClinicalTrials.gov Archive Site
  • 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).
PIDs [ Time Frame: at 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours post-dose. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dental Pain
  • Drug: Diclofenac HPBCD
    1 single injection at day of dental surgical extraction
  • Other: Placebo s.c.
    1 single injection at day of dental surgical extraction
  • Experimental: Diclofenac HPBCD s.c. 25mg/ml
    Intervention: Drug: Diclofenac HPBCD
  • Experimental: Diclofenac HPBCD s.c. 50mg/ml
    Intervention: Drug: Diclofenac HPBCD
  • Active Comparator: Diclofenac HPBCD s.c. 75mg/ml
    Intervention: Drug: Diclofenac HPBCD
  • Placebo Comparator: Placebo s.c. (1ml)
    Intervention: Other: Placebo s.c.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
April 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland,   United Kingdom
 
NCT00942448
09PUK-DCsc04
No
IBSA Institut Biochimique SA
IBSA Institut Biochimique SA
Not Provided
Principal Investigator: Thomas Dietrich, Prof The school of dentistry, University of Birmingham
IBSA Institut Biochimique SA
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP