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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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19 March 2012 |
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Main ID: |
EUCTR2004-000404-40-IT |
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Date of registration:
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15/03/2005 |
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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 double blind, randomised, placebo-controlled study to investigate chronic intermittent ''pulse'' therapy of moxifloxacin as a prevention of acute exacerbation in out-patients with chronic bronchitis
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Scientific title:
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A double blind, randomised, placebo-controlled study to investigate chronic intermittent ''pulse'' therapy of moxifloxacin as a prevention of acute exacerbation in out-patients with chronic bronchitis |
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Date of first enrolment:
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03/08/2004 |
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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:2004-000404-40 |
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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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Ireland
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Italy
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Spain
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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) 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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Prevention of acute exacerbation of chronic bronchitis
MedDRA version: Nd
Level: PT
Classification code 10061735
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Intervention(s)
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Trade Name: AVALOX* 5CPR 400MG BL PP/AL
Pharmaceutical Form: Tablet
INN or Proposed INN: Moxifloxacin
Current Sponsor code: BAY 12-8039
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
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Primary Outcome(s)
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Secondary Objective:
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Main Objective:
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Primary end point(s):
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Secondary ID(s)
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2004-000404-40-IE
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BAY 12-8039/11229 PULSE
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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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