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 is currently recruiting participants.

Verified by IBSA Institut Biochimique SA, November 2009

First Received: July 17, 2009 Last Updated: November 6, 2009 History of Changes

Sponsor:	IBSA Institut Biochimique SA
Information provided by:	IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:	NCT00942448

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
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:

MedlinePlus related topics: Surgery

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	300
Study Start Date:	September 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Diclofenac HPBCD s.c. 25mg/ml: Experimental	Drug: Diclofenac HPBCD 1 single injection at day of dental surgical extraction
Diclofenac HPBCD s.c. 50mg/ml: Experimental	Drug: Diclofenac HPBCD 1 single injection at day of dental surgical extraction
Diclofenac HPBCD s.c. 75mg/ml: Active Comparator	Drug: Diclofenac HPBCD 1 single injection at day of dental surgical extraction
Placebo s.c. (1ml): Placebo Comparator	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

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

Contacts

Contact: Gugliotta, PharmD

+41 58 360 10 00

barbara.gugliotta@ibsa.ch

Locations

Poland
NZOZ Polimedica	Recruiting
Zgierz, Poland, 95-100
Contact: Dr Zielińska-Kaźmierska
Centrum Leczenia Chorób Cywilizacyjnych	Recruiting
Warszawa, Poland, 02-797
Contact: Dr Opadczuk
Niepubliczny Zakład Opieki Zdrowotnej	Recruiting
Warszawa, Poland, 03-252
Contact: Dr Kozieł
Gabinet Stomatologiczny Bartek	Recruiting
Kobyłka, Poland, 05-230
Contact: Dr Miklaszewski
United Kingdom
Eastman Dental Institute, University College London	Not yet recruiting
London, United Kingdom, WC1X8LD
Contact: Dr Leeson
The School of Dentistry; University of Birmingham	Recruiting
Birmingham, United Kingdom, B4 6NN
Contact: Prof. Dietrich

Sponsors and Collaborators

IBSA Institut Biochimique SA

More Information

No publications provided

Responsible Party:	IBSA Institut Biochimique ( Barbara Gugliotta, PharmD/Clinical Research Manager )
Study ID Numbers:	09PUK-DCsc04
Study First Received:	July 17, 2009
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT00942448 History of Changes
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:

Anti-Inflammatory Agents
Tooth Diseases
Molecular Mechanisms of Pharmacological Action
Facial Pain
Toothache
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Diclofenac
Enzyme Inhibitors
Pain
Pharmacologic Actions

Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Stomatognathic Diseases
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010