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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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8 May 2017 |
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Main ID: |
EUCTR2013-000499-14-FR |
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Date of registration:
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25/09/2015 |
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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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N/A
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Scientific title:
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N/A - ALLOZITHRO |
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Date of first enrolment:
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30/08/2013 |
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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:2013-000499-14 |
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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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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Are the trial subjects under 18? yes
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) no
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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MedDRA version: 18.0
Level: LLT
Classification code 10049202
Term: Bronchiolitis obliterans
System Organ Class: 100000004855
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Intervention(s)
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Trade Name: AZITHROMYCINE 250 mg
Product Name: AZITHROMYCINE 250 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: AZITHROMYCINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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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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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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