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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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1 May 2012 |
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Main ID: |
EUCTR2004-001101-10-IT |
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Date of registration:
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12/07/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A prospective, multicenter, randomized phase III study to evaluate the efficacy of ZOMETA (zoledronic acid) in preventing or delaying of bone metastasis in patients with
Stage III non-small cell lung cancer
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Scientific title:
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A prospective, multicenter, randomized phase III study to evaluate the efficacy of ZOMETA (zoledronic acid) in preventing or delaying of bone metastasis in patients with
Stage III non-small cell lung cancer |
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Date of first enrolment:
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26/07/2005 |
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Target sample size:
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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:2004-001101-10 |
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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:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Belgium
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Hungary
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Italy
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Spain
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United Kingdom
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Contacts
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Email:
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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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Prevention of bone metastasis in patients with non small cell lung cancer Stage III.
MedDRA version: 6.1
Level: PT
Classification code 10029519
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Intervention(s)
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Product Name: ZOLEDRONIC ACID
Product Code: ZOL446
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Zoledronic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
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Primary Outcome(s)
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Secondary Objective:
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Primary end point(s):
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Main Objective:
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Secondary ID(s)
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2004-001101-10-HU
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CZOL446G2419
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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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