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Main
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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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22 April 2013 |
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Main ID: |
EUCTR2005-000541-11-DK |
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Date of registration:
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21/02/2005 |
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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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Glukosaminsulfat og hyperkolesterolæmi
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Scientific title:
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Glukosaminsulfat og hyperkolesterolæmi |
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Date of first enrolment:
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31/03/2005 |
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Target sample size:
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66 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000541-11 |
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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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Countries of recruitment
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Denmark
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients do understand the studyprotocol (popular edition)
Symptoms of osteoarthritis.
40 years or older.
No intake of glucosamine for at least 3 months.
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:
Severe illness (fx heart disease, cancer, inflammation illnesses as fx cronic Rheumatoid arthritis).
Medicine (other than painkillers as paracetamol and NSAID)
Change or planing a change in diet or physical activity
Abuse of alcohol
Pregnant or nursing
Allergy to shellfish
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Intervention(s)
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Trade Name: Glucosamin Pharma Nord
Product Name: Glucosamin Pharma Nord
Product Code: 460
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Glucosamine
CAS Number: 3416-24-8
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 380 mg-420 mg
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: Investigate the effect of glucosamine supplementation on lipoproteins (cholesterol) and triglycerides in patients with mild to moderate osteoarthritis.
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Primary end point(s): Cholesterol and triglyceride concentration in the blood.
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Secondary Objective: Symptom change
Adverse effects
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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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