Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Dental Pain

Intervention / Treatment
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* Drug: Diclofenac HPBCD
* Drug: Diclofenac HPBCD
* Drug: Diclofenac HPBCD
* Other: Placebo s.c.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac HPBCD s.c. 25mg/ml<br> | Drug: Diclofenac HPBCD<br>* 1 single injection at day of dental surgical extraction<br>|
| Experimental: Diclofenac HPBCD s.c. 50mg/ml<br> | Drug: Diclofenac HPBCD<br>* 1 single injection at day of dental surgical extraction<br>|
| Active Comparator: Diclofenac HPBCD s.c. 75mg/ml<br> | Drug: Diclofenac HPBCD<br>* 1 single injection at day of dental surgical extraction<br>|
| Placebo Comparator: Placebo s.c. (1ml)<br> | Other: Placebo s.c.<br>* 1 single injection at day of dental surgical extraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Difference (PID) on a 0-100 VAS | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | at 1.5 hours after treatment administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | at 15 minutes post-dose. | 
| PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | at 30 minutes post-dose. | 
| PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | at 45 minutes post-dose. | 
| PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | at 60 minutes post-dose. | 
| PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | at 90 minutes post-dose. | 
| PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | at 2 hours post-dose. | 
| PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | at 3 hours post-dose. | 
| PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | at 4 hours post-dose. | 
| PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | at 5 hours post-dose. | 
| PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | at 6 hours post-dose. | 
| PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | at 7 hours post-dose. | 
| PID | Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable). | at 8 hours post-dose. |