A multicenter, randomized, double blind, placebo controlled Phase III study to assess the efficacy of xaliproden in patients with oxaliplatin-induced peripheral sensory neuropathy (PSN) following adju...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-000945-36

A multicenter, randomized, double blind, placebo controlled Phase III study to assess the efficacy of xaliproden in patients with oxaliplatin-induced peripheral sensory neuropathy (PSN) following adjuvant chemotherapy for colon cancer

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Extrait

To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of PSN at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer


Critère d'inclusion

  • Patient with oxaliplatin-induced peripheral sensory neuropathy after having completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colorectal tumor