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Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens

NCT00603577 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2016-05-05

No results posted yet for this study

Summary

Primary objective:

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

Secondary objective:

* To assess the effect of xaliproden on patient-reported outcomes using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale (FACT/GOG NTX-12 subscale).
* To assess the effect of xaliproden on the rate of at least partial recovery of grade \> 2 PSN at 6 months
* To assess the effects of xaliproden on the time to complete recovery from PSN
* To evaluate the safety profile of xaliproden

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

Placebo

Xaliproden matching placebo. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).

DRUG

Xaliproden

1.0 mg capsule. 1 capsule per day for 6 months or until resolution of PSN (whichever comes first).

Sponsors & Collaborators

Principal Investigators

  • Jean-Philippe Aussel · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00603577 on ClinicalTrials.gov