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

Tracking Information
First Submitted Date ICMJE	July 17, 2009
First Posted Date ICMJE	July 21, 2009
Results First Submitted Date	November 16, 2012
Results First Posted Date	January 28, 2013
Last Update Posted Date	January 28, 2013
Study Start Date ICMJE	September 2009
Actual Primary Completion Date	January 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 17, 2012)	Pain Intensity Difference (PID) on a 0-100 VAS [ Time Frame: at 1.5 hours after treatment administration ]; 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).
Original Primary Outcome Measures ICMJE; (submitted: July 20, 2009)	Pain Intensity Difference (PID) on a 0-100 VAS [ Time Frame: at 1.5 hours after treatment administration ]
Change History	Complete list of historical versions of study NCT00942448 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 17, 2012)	PID [ Time Frame: at 15 minutes post-dose. ]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. ]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. ]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. ]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. ]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. ]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. ]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. ]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. ]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. ]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. ]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. ]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).
Original Secondary Outcome Measures ICMJE; (submitted: July 20, 2009)	PID [ Time Frame: at 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours post-dose. ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery
Official Title ICMJE	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)
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Dental Pain
Intervention ICMJE	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
Study Arms	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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 17, 2012)	306
Original Estimated Enrollment ICMJE; (submitted: July 20, 2009)	300
Actual Study Completion Date	April 2010
Actual Primary Completion Date	January 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Poland, United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00942448
Other Study ID Numbers ICMJE	09PUK-DCsc04
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	IBSA Institut Biochimique SA
Study Sponsor ICMJE	IBSA Institut Biochimique SA
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Thomas Dietrich, Prof The school of dentistry, University of Birmingham
PRS Account	IBSA Institut Biochimique SA
Verification Date	February 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP