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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01446783
Date of registration: 27/09/2011
Prospective Registration: No
Primary sponsor: Bispebjerg Hospital
Public title: IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients
Scientific title: IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients
Date of first enrolment: September 2011
Target sample size: 15
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01446783
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science  
Phase:  N/A
Countries of recruitment
Denmark
Contacts
Name:     Michael Kjaer, Professor
Address: 
Telephone:
Email:
Affiliation:  Institute of Sportsmedicine Copenhagen
Key inclusion & exclusion criteria

Inclusion Criteria:

- Classic form of Ehlers-Danlos syndrome OR healthy matched control

Exclusion Criteria:

- Malignity, cardiac diseases, diabetes, tendinopathy in patella tendons



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Ehlers-Danlos Syndrome, Classic
Intervention(s)
Drug: mecasermin
Drug: Saline
Primary Outcome(s)
Fractional synthesis rate of collagen in tendon, muscle and skin [Time Frame: 6 hours]
Secondary Outcome(s)
Electron microscopy [Time Frame: No]
mRNA [Time Frame: No]
Secondary ID(s)
H-1-2011-010
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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