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

Dental Pain Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942448
• Other study ID #: 09PUK-DCsc04
• Status: Completed
• Phase: Phase 3
• First received: July 17, 2009
• Last updated: December 17, 2012
• Start date: September 2009
• Est. completion date: April 2010

Study information

• Verified date: February 2011
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: April 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pain

Intervention

Drug:
• Diclofenac HPBCD
1 single injection at day of dental surgical extraction
• Diclofenac HPBCD
1 single injection at day of dental surgical extraction
• Diclofenac HPBCD
1 single injection at day of dental surgical extraction

Other:
• Placebo s.c.
1 single injection at day of dental surgical extraction

Locations

Country	Name	City	State
Poland	Gabinet Stomatologiczny Bartek	Kobylka
Poland	Centrum Leczenia Chorób Cywilizacyjnych	Warszawa
Poland	Niepubliczny Zaklad Opieki Zdrowotnej	Warszawa
Poland	NZOZ Polimedica	Zgierz
United Kingdom	The School of Dentistry; University of Birmingham	Birmingham
United Kingdom	Eastman Dental Institute, University College London	London

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Countries where clinical trial is conducted

Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Difference (PID) on a 0-100 VAS	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).	at 1.5 hours after treatment administration	No
Secondary	PID	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).	at 15 minutes post-dose.	No
Secondary	PID	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).	at 30 minutes post-dose.	No
Secondary	PID	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).	at 45 minutes post-dose.	No
Secondary	PID	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).	at 60 minutes post-dose.	No
Secondary	PID	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).	at 90 minutes post-dose.	No
Secondary	PID	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).	at 2 hours post-dose.	No
Secondary	PID	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).	at 3 hours post-dose.	No
Secondary	PID	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).	at 4 hours post-dose.	No
Secondary	PID	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).	at 5 hours post-dose.	No
Secondary	PID	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).	at 6 hours post-dose.	No
Secondary	PID	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).	at 7 hours post-dose.	No
Secondary	PID	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).	at 8 hours post-dose.	No