Phase 3
N=306
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery
Dental Pain
Bottom Line
View on ClinicalTrials.gov: NCT00942448 ↗Enrolled (actual)
306
Serious AEs
0.3%
Results posted
Jan 2013
Primary outcome: Primary: Pain Intensity Difference (PID) on a 0-100 VAS — 36.5; 37.3; 37.7; 12.3 mm — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Diclofenac HPBCD (Drug); Placebo s.c. (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- IBSA Institut Biochimique SA
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity Difference (PID) on a 0-100 VAS |
36.5; 37.3; 37.7; 12.3 | < 0.001 sig |
| SECONDARY PID |
45.0; 43.8; 43.6; 37.0 | — |
| SECONDARY PID |
45.0; 43.8; 43.6; 37.0 | — |
| SECONDARY PID |
45.0; 43.8; 43.6; 37.0 | — |
| SECONDARY PID |
45.0; 43.8; 43.6; 37.0 | — |
| SECONDARY PID |
45.0; 43.8; 43.6; 37.0 | — |
| SECONDARY PID |
45.0; 43.8; 43.6; 37.0 | — |
| SECONDARY PID |
45.0; 43.8; 43.6; 37.0 | — |
| SECONDARY PID |
45.0; 43.8; 43.6; 37.0 | — |
| SECONDARY PID |
45.0; 43.8; 43.6; 37.0 | — |
| SECONDARY PID |
45.0; 43.8; 43.6; 37.0 | — |
| SECONDARY PID |
45.0; 43.8; 43.6; 37.0 | — |
| SECONDARY PID |
45.0; 43.8; 43.6; 37.0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00942448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.