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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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18 April 2012 |
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Main ID: |
EUCTR2005-002570-30-IT |
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Date of registration:
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25/01/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A multicenter randomized, double-blind placebo controlled phase III study of the efficacy of Xaliproden in preventing the neurotoxicity of oxaliplatin in first-line treatment of patients with metastatic colorectal cancer treated with oxaliplatin/5FU/LV
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Scientific title:
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A multicenter randomized, double-blind placebo controlled phase III study of the efficacy of Xaliproden in preventing the neurotoxicity of oxaliplatin in first-line treatment of patients with metastatic colorectal cancer treated with oxaliplatin/5FU/LV |
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Date of first enrolment:
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25/11/2005 |
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Target sample size:
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900 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002570-30 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Germany
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Hungary
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Italy
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Portugal
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Spain
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Patients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LV at risk of cumulative peripheral sensory neuropathy PSN relative to cumulative dose of oxaliplatin.
MedDRA version: 6.1
Level: PT
Classification code 10034620
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Intervention(s)
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Product Name: xaliproden
Product Code: SR57746A
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Xaliproden
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
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Primary Outcome(s)
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Main Objective:
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Primary end point(s):
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Secondary Objective:
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Secondary ID(s)
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2005-002570-30-GB
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EFC5505
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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