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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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01109017 |
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Date of registration:
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19/04/2010 |
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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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Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency
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Scientific title:
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A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Long-term Safety and Efficacy of Norditropin® Formulation in Patients With AGHD |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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387 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01109017 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Japan
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Severe adult growth hormone deficiency
Exclusion Criteria:
- Known or suspected allergy to study product(s) or related products
- Previous participation in the study
- Diabetes Mellitus
- Presence of malignant tumor(s)
- Pregnant or likely to get pregnant
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adult Growth Hormone Deficiency
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Growth Hormone Disorder
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Intervention(s)
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Drug: somatropin
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Primary Outcome(s)
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Number and type of suspected serious adverse drug reactions (SADRs) during the study period
[Time Frame: after 5 years]
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Secondary Outcome(s)
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Effects on body composition (body fat percentage, lean body weight mass, bone density, bone mineral density)
[Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years]
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Number of impaired glucose tolerance events during the study period
[Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years]
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Effects of insulin-like growth factor-1 (IGF-I) levels
[Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years]
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Number of other types of adverse events (AEs) during the study period
[Time Frame: evaluated after 3 months, 6 months, 1 year and between 2-5 years]
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Secondary ID(s)
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U1111-1114-6250
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JapicCTI-101122
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GH-3811
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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