Clinical trial NCT00943098: Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Pain
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2009-07-22
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Pain Intensity Difference (PID)
timeFrame: 1.5 hours
Secondary outcomes:
measure: PIDs
timeFrame: at 15 minutes post-dose.
measure: PIDs
timeFrame: at 30 minutes post-dose.
measure: PIDs
timeFrame: at 45 minutes post-dose.
measure: PIDs
timeFrame: at 60 minutes post-dose.
measure: PIDs
timeFrame: at 90 minutes post-dose.
measure: PIDs
timeFrame: at 2 hours post-dose.
measure: PIDs
timeFrame: at 3 hours post-dose.
measure: PIDs
timeFrame: at 4 hours post-dose.
measure: PIDs
timeFrame: at 5 hours post-dose.
measure: PIDs
timeFrame: at 6 hours post-dose.
measure: PIDs
timeFrame: at 7 hours post-dose.
measure: PIDs
timeFrame: at 8 hours post-dose.
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: The School of Dentistry, University of Birmingham
city: Cardiff
country: United Kingdom
facility: Department of oral Surgery; University Dental Hospital
city: Sheffield
country: United Kingdom
facility: The School of Clinical Dentistry, The University of Sheffield
Study officials:
affiliation: The school of Clinical Dentistry
name: Ian Brook, Prof
role: PRINCIPAL_INVESTIGATOR
References: