Status:
COMPLETED
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery
Lead Sponsor:
IBSA Institut Biochimique SA
Conditions:
Dental Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT00942448
Start Date
September 1 2009
End Date
April 1 2010
Last Update
January 28 2013
Active Locations (6)
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1
Gabinet Stomatologiczny Bartek
Kobyłka, Poland, 05-230
2
Centrum Leczenia Chorób Cywilizacyjnych
Warsaw, Poland, 02-797
3
Niepubliczny Zakład Opieki Zdrowotnej
Warsaw, Poland, 03-252
4
NZOZ Polimedica
Zgierz, Poland, 95-100