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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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5 December 2016 |
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Main ID: |
EUCTR2007-001401-15-DK |
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Date of registration:
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14/04/2010 |
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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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Treatment of patients with cystic fibrosis with N-acetylcysteine
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Scientific title:
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Treatment of patients with cystic fibrosis with N-acetylcysteine |
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Date of first enrolment:
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21/05/2010 |
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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:2007-001401-15 |
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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: no
Placebo: no
Other: yes
Other specify the comparator: no medication
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Denmark
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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. Adults (18-50 yrs).
2. Male and female. No fertile women - negative pregnancy test - use anticonception)
3. Patients are included at the end of a routine 2 wk antibiotic course
4. Included patients are caucasians
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:
1. Hypersensitivity to ACC
2. Lung transplanted patients or patients waiting for LTX
3. Patients not treated with ACC 30 days before inclusion
4. Lack of compliance.
5. Patients with recent hemoptysis (within 14 days).
6. Patients with increased liver enzymes i.e. ALAT more than twice normal values (10-70U/L).
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 cystic fibrosis and chronic Pseudomonas lung infection
MedDRA version: 12.1
Level: LLT
Classification code 10011763
Term: Cystic fibrosis lung
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Intervention(s)
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Trade Name: ACC600Tabs
Product Name: N-acetylcystein
Product Code: R05C B01
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLCYSTEINE
CAS Number: 616-91-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
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Primary Outcome(s)
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Primary end point(s): 1. Oxidative stress markers (MDA, 8oxodG in urine)
2. Antioxidant status: vit C, oxidised vit C, a- og g-tokoferol, b-caroten, lycopen, plasma oxidazibility.
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Main Objective: pilotstudy to investigate level and individual variation of oxidative stress markers and effect of one month treatment on these variables on the lung fundtion
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Secondary Objective: results will be used for power calculation for a large clinical study
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Secondary ID(s)
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Rigshospitalet
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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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