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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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27 May 2013 |
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Main ID: |
EUCTR2010-023828-24-GB |
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Date of registration:
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27/04/2011 |
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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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The effect of Thalidomide on sputum biomarkers in IPF cough.
- The effect of Thalidomide on sputum biomarkers in IPF cough
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Scientific title:
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The effect of Thalidomide on sputum biomarkers in IPF cough.
- The effect of Thalidomide on sputum biomarkers in IPF cough |
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Date of first enrolment:
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09/06/2011 |
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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:2010-023828-24 |
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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: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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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:
1.Diagnosis of Pulmonary Fibrosis (including idiopathic, hypersensitivity, non specific Interstitial pneumonitis) as per International consensus/ guidelines.
2.Cough
3.Age>50/ Non child bearing potential
Are the trial subjects under 18?
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:
Clinical Reflux
Subclinical reflux
Unable to give informed consent
Women of childbearing age
Peripheral neuropathy
Risk for TED including:
Major co-morbidity including medication known to interact with thalidomide
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Cough in Idiopathic Pulmonary fibrosis.
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Intervention(s)
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Trade Name: Thalidomide Pharmion
Product Name: Thalidomide Pharmion
Pharmaceutical Form: Capsule
Trade Name: PREDNISOLONE
Product Name: prednisolone
Pharmaceutical Form: Tablet
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Primary Outcome(s)
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Main Objective: We want to explore the effect of Thalidomide on sputum and blood biomarkers in IPF cough.
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Secondary Objective: To measure cough and assess if thalidomide improves it.
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Primary end point(s): The difference in biomarker in sputum and blood at beginning and end of study.
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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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