Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery
NCT ID: NCT00942448
Last Updated: 2013-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
306 participants
INTERVENTIONAL
2009-09-30
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Diclofenac HPBCD s.c. 25mg/ml
Diclofenac HPBCD
1 single injection at day of dental surgical extraction
Diclofenac HPBCD s.c. 50mg/ml
Diclofenac HPBCD
1 single injection at day of dental surgical extraction
Diclofenac HPBCD s.c. 75mg/ml
Diclofenac HPBCD
1 single injection at day of dental surgical extraction
Placebo s.c. (1ml)
Placebo s.c.
1 single injection at day of dental surgical extraction
Interventions
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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
Placebo s.c.
1 single injection at day of dental surgical extraction
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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IBSA Institut Biochimique SA
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Dietrich, Prof
Role: PRINCIPAL_INVESTIGATOR
The school of dentistry, University of Birmingham
Locations
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Gabinet Stomatologiczny Bartek
Kobyłka, , Poland
Centrum Leczenia Chorób Cywilizacyjnych
Warsaw, , Poland
Niepubliczny Zakład Opieki Zdrowotnej
Warsaw, , Poland
NZOZ Polimedica
Zgierz, , Poland
The School of Dentistry; University of Birmingham
Birmingham, , United Kingdom
Eastman Dental Institute, University College London
London, , United Kingdom
Countries
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Other Identifiers
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09PUK-DCsc04
Identifier Type: -
Identifier Source: org_study_id
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