Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in 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 s.c. 75mg/ml (Drug); Voltarol 75mg/3ml i.m. (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: IBSA Institut Biochimique SA Overall contact:
Barbara Gugliotta, PharmD, Phone: +41 58 360 10 00, Email: barbara.gugliotta@ibsa.ch
Summary
The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD
75mg/1ml s. c. with the marketed reference product, Voltarol® 75mg/3ml i. m. in the treatment
of acute moderate-to-severe pain after dental impaction surgery.
Clinical Details
Official title: Efficacy and Safety of a Single s.c. Diclofenac HPBCD 75mg/1ml Injection as Compared to a Single i.m. Voltarol® 75mg/3ml, in the Treatment of Acute Moderate-to-severe Post-surgical Pain Following Dental Surgery (Impacted 3rd Molar Removal).
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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
Barbara Gugliotta, PharmD, Phone: +41 58 360 10 00, Email: barbara.gugliotta@ibsa.ch
NZOZ Specjalistyczna Praktyka Stomatologii Estetycznej i Periodontologii, Białystok, Poland
Niepubliczny Zakład Opieki Zdrowotnej "Medica", Giżycko, Poland
Indywidualna Specjalistyczna Praktyka Lekarska, Anna Kuźmiuk, Białystok, Poland
Leeds Dental Institute, Leeds, United Kingdom
The School of Clinical Dentistry, Sheffield, United Kingdom
Additional Information
Starting date: September 2009
Ending date: June 2010
Last updated: September 17, 2009
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