NCT01450163 - Evaluate The Efficacy and Safety Of Pregabalin In Prevention, Reduction of Oxaliplatin-Induced Painful Neuropathy | Biotech Hunter

Enrollment

200

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

October 31, 2014

Study Completion Date

December 31, 2014

Conditions

PainNeuropathic PainPolyneuropathy

Interventions

DRUG

Pregabalin, Oxaliplatin

Oxaliplatin will be infused according to the FLOX treatment strategy, as a regular six-month-long adjuvant treatment to colorectal cancer. Pregabalin will be administered P.O. three days before and three days after each of the nine Ox infusions. The dose will be titrated during the first Ox infusion to the highest level tolerated by the patient. The dose used in this first session will be used in the eight following sessions.

DRUG

Placebo , Oxaliplatin

Oxaliplatin will be infused according to the FLOX treatment strategy, as a regular six-month-long adjuvant treatment to colorectal cancer. Placebo will be administered P.O. three days before and three days after each of the nine Ox infusions. The dose will be titrated during the first Ox infusion to the highest level tolerated by the patient. The dose used in this first session will be used in the eight following sessions.

Trial Locations (1)

01246-000

Instituto do Câncer do Estado de São Paulo ICESP, São Paulo