Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery
Information source: IBSA Institut Biochimique SA
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dental Pain
Intervention: Diclofenac HPBCD (Drug); Diclofenac HPBCD (Drug); Diclofenac HPBCD (Drug); Placebo s.c. (Other)
Phase: Phase 3
Status: Recruiting
Sponsored by: IBSA Institut Biochimique SA Overall contact:
Gugliotta, PharmD, Phone: +41 58 360 10 00, Email: barbara.gugliotta@ibsa.ch
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.
Clinical Details
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)
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Primary outcome: pain intensity difference (PID) on a 0-100 VAS
Secondary outcome: PIDs
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Gugliotta, PharmD, Phone: +41 58 360 10 00, Email: barbara.gugliotta@ibsa.ch
NZOZ Polimedica, Zgierz 95-100, Poland; Recruiting
Dr Zielińska-Kaźmierska
Centrum Leczenia Chorób Cywilizacyjnych, Warszawa 02-797, Poland; Recruiting
Dr Opadczuk
Niepubliczny Zakład Opieki Zdrowotnej, Warszawa 03-252, Poland; Recruiting
Dr Kozieł
Gabinet Stomatologiczny Bartek, Kobyłka 05-230, Poland; Not yet recruiting
Dr Miklaszewski
Eastman Dental Institute, University College London, London WC1X8LD, United Kingdom; Not yet recruiting
Dr Leeson
Additional Information
Starting date: September 2009
Ending date: June 2010
Last updated: September 18, 2009
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