NCT00380874

Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer

A Randomized, Double-Blind, Placebo-Controlled Trial Of The Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy Symptoms In Subjects With Advanced Colorectal Cancer

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy.

Detailed description

This study was terminated on July 15, 2008. The results of an interim analysis showed that the conditional power to detect a difference in treatment groups was insufficient to warrant study continuation and therefore termination of the trial was recommended. The decision to terminate the trial was not based on safety concerns.

Conditions

• Chemotherapy-Induced Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	Pregabalin	150- 600 mg/day (double blind in divided doses)
DRUG	Placebo	Placebo

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2006-09-27
• Last updated: 2021-02-11
• Results posted: 2009-04-17

Locations

15 sites across 6 countries: Australia, Germany, Italy, South Korea, Spain, Taiwan