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

• PID [ Time Frame: at 15 minutes post-dose. ] [ Designated as safety issue: No ]
  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).
• PID [ Time Frame: at 30 minutes post-dose. ] [ Designated as safety issue: No ]
  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).
• PID [ Time Frame: at 45 minutes post-dose. ] [ Designated as safety issue: No ]
  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).
• PID [ Time Frame: at 60 minutes post-dose. ] [ Designated as safety issue: No ]
  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).
• PID [ Time Frame: at 90 minutes post-dose. ] [ Designated as safety issue: No ]
  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).
• PID [ Time Frame: at 2 hours post-dose. ] [ Designated as safety issue: No ]
  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).
• PID [ Time Frame: at 3 hours post-dose. ] [ Designated as safety issue: No ]
  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).
• PID [ Time Frame: at 4 hours post-dose. ] [ Designated as safety issue: No ]
  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).
• PID [ Time Frame: at 5 hours post-dose. ] [ Designated as safety issue: No ]
  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).
• PID [ Time Frame: at 6 hours post-dose. ] [ Designated as safety issue: No ]
  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).
• PID [ Time Frame: at 7 hours post-dose. ] [ Designated as safety issue: No ]
  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).
• PID [ Time Frame: at 8 hours post-dose. ] [ Designated as safety issue: No ]
  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).

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.

• Drug: Diclofenac HPBCD
  1 single injection at day of dental surgical extraction
• Other: Placebo s.c.
  1 single injection at day of dental surgical extraction

• Experimental: Diclofenac HPBCD s.c. 25mg/ml
  Intervention: Drug: Diclofenac HPBCD
• Experimental: Diclofenac HPBCD s.c. 50mg/ml
  Intervention: Drug: Diclofenac HPBCD
• Active Comparator: Diclofenac HPBCD s.c. 75mg/ml
  Intervention: Drug: Diclofenac HPBCD
• Placebo Comparator: Placebo s.c. (1ml)
  Intervention: Other: Placebo s.c.

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.