09PUK/DCsc04 - Version 1 of 20/04/2009

• Research type

  Research Study

• Full title

  Multicentre, randomised, double-blind, active comparator- and placebo-controlled, parallel-group phase III clinical study, for the evaluation of the efficacy and safety 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)

• IRAS ID

  24382

• Eudract number

  2009-011663-37

• ISRCTN Number

  N/A

• Research summary

  The research consists of 4 visits. Patients enrolled in the study will be required to visit the investigational site on at least 4 separate occasions: * Visit 0 (day -30/-1): medical history, blood pressure, heart rate, routine laboratory test ( pregnancy test for females of child bearing potential)& preliminary eligibility assessment, oral examination, trismus evaluation ( how far the mouth opens);* Visit 1 (day 1): , blood pressure, heart rate, pregnancy test for females of child bearing potential, eligibility assessment, surgery & study treatment administration, patient diary to measure pain using VAS, rescue medication administered if necessary.* Visit 2 (day 2): post-surgery control visit, vital signs, oral examination, patient diary to measure pain using VAS, rescue medication administered if necessary.* Visit 3 (day 7 ñ 2): final safety visit. blood pressure, heart rate, routine laboratory test, oral examination, trismus evaluation.There may be a need for an unplanned visit (optional) for safety reasons between Visit 2 and Visit 3 in the post-operative period. After surgery, patients will be asked to score their pain by drawing a mark on a line - Visual Analogue Scale (VAS. Those who still have pain post-operative = 50 mm on a Visual Analogue Scale (VAS) within 6 hours from end of surgery will be randomised (like tossing a coin)to one of four possible treatment regimens:Group 1: one 1.0 ml ampoule of 25 mg Diclofenac HPBCD administered s.c.;Group 2: one 1.0 ml ampoule of 50 mg Diclofenac HPBCD administered s.c.;Group 3: one 1.0 ml ampoule of 75 mg Diclofenac HPBCD administered s.c.;Group 4: one 1.0 ml placebo administered s.c.;If the patients given medication, (above) not providing pain relief, the patient will be allowed to use a rescue medication (paracetamol tablets). In case of worsening or intolerable pain at any time during the study, the patient will receive an alternative analgesic treatment based on Investigator's judgement and will be withdrawn from the study.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  09/H1208/28

• Date of REC Opinion

  28 Jul 2009

• REC opinion

  Further Information Favourable Opinion