To study the analgesic effect of a combination of DKP.TRIS & TRAM.HCL

• Research type

  Research Study

• Full title

  Double-blind, randomised, placebo and active controlled, parallel group study to evaluate the analgesic effect of a single oral administration of four different combination doses of DKP.TRIS with TRAM.HCl in comparison with the single agents, on moderate to severe pain following impacted third mandibular molar tooth extraction

• IRAS ID

  66581

• Contact name

  Michael Hill

• Sponsor organisation

  Menarini Ricerche S.p.A.

• Eudract number

  2010-022798-32

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  Double-blind, randomised, placebo and active controlled study to evaluate the pain-relief effect of a single oral administration of four different combination doses of DKP.TRIS with TRAM.HCl in comparison with the single agents, on moderate to severe pain following wisdom tooth extraction-----------------------------------------------------------------------This study is being conducted to evaluate how effective DKP.TRIS and TRAM.HCl (commercially available pain medication) are in relieving pain, when given as fixed combinations and when given as single components in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth removal. Five countries in Europe are participating in this study including the UK. Approximately 600 patients that will have a wisdom tooth extraction and experience moderate to severe pain within 3 hours after the surgery are planned to participate in this study. In the UK the study will be performed by suitably qualified doctors or dentists at NHS hospitals across the country. This study will last for approximately 30 days and includes 3 visits to the hospital.Participants will be randomised to a total of 10 treatment groups including 4 combinations of DKP.TRIS TRAM.HCl (12.5 mg 37.5 mg, 12.5 mg 75 mg, 25 mg 37.5 mg and 25 mg 75 mg) and the four corresponding single treatments, and placebo, with ibuprofen 400 mg as an active control. The participant will have a 1 in 10 chance of receiving placebo. If the participant feels that there is no relief from the pain, rescue medication will be provided (paracetamol). The participant will have to undergo a physical examination, blood and urine tests, ECGs and complete questionnaires and an electronic diary for the intensity of the pain.

• REC name

  Wales REC 3

• REC reference

  10/MRE09/44

• Date of REC Opinion

  14 Dec 2010

• REC opinion

  Favourable Opinion