09PUK/Dcsc05-Version 1 dated 14.05.2009

• Research type

  Research Study

• Full title

  Multicentre, randomised, double-blind (double-dummy), active comparator-controlled, phase III study of the 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).

• IRAS ID

  24761

• Contact name

  Ian Brook

• Eudract number

  2009-011980-35

• ISRCTN Number

  n/a

• Research summary

  The research consists of 4 visits: ?½ 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. ?½ 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. ?½ Visit 2 (day 2): post-surgery control visit, vital signs, rescue medication administered if necessary. ?½ Visit 3 (day 7 ñ 2): final safety visit. blood pressure, heart rate, routine laboratory test, oral examination. 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 two possible treatment groups: Group 1: one 1.0 ml ampoule of 75 mg Diclofenac HPBCD administered s.c. one 3.0 ml ampoule of placebo administered i.m. Group 2: one 3.0 ml ampoule of 75 mg Voltarol administered i.m. one 1.0 ml ampoule of 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the study, the patient will receive an alternative analgesic treatment based on Investigator's judgement and will be withdrawn from the study.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

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  09/H1306/74

• Date of REC Opinion

  3 Aug 2009

• REC opinion

  Further Information Favourable Opinion