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An open-label, randomized, parallel-group, monocenter study to evaluate safety and efficacy of Oxycodone Hydrochloride administered orally (CR) and intravenously in patients with total hip endoprosthe...

Update Il y a 4 ans
Reference: EUCTR2005-001791-13

An open-label, randomized, parallel-group, monocenter study to evaluate safety and efficacy of Oxycodone Hydrochloride administered orally (CR) and intravenously in patients with total hip endoprosthesis in comparison to total hip endoprosthesis patients with additional oral (CR) Oxycodone Hydrochloride premedication

Woman and Man

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Extract

The primary objective is to evaluate whether the analgesia of Oxycodone Hydrochloride CR tablets administered orally and Oxycodone Hydrochloride Injection Solution administered intravenously in combination with an oral premedication of Oxycodone Hydrochloride CR tablets is superior in comparison to Oxycodone Hydrochloride CR tablets administered orally and Oxycodone Hydrochloride Injection Solution administered intravenously without an oral premedication of Oxycodone Hydrochloride CR tablets. Both treatment groups (premedication / no premedication) receive additionally diclofenac colestyramine CR capsules. Differences between both treatment groups will be investigated by the need for analgesics in general and the relative frequency of dose increase respectively.

Inclusion criteria

  • Male and female patients who are designated for a total hip endoprosthesis

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