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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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11 March 2024 |
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Main ID: |
NCT01562834 |
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Date of registration:
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22/03/2012 |
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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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Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients
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Scientific title:
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Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients |
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Date of first enrolment:
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October 21, 1998 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01562834 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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France
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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:
- Childhood or adult onset growth hormone deficiency (GHD)
- GHD evidenced by two stimulation tests
- Duration of GHD at least 5 years
- Other hormone deficiencies associated with growth hormone deficiency
Exclusion Criteria:
- Pregnancy or pregnancy desired during the suggested duration of the study
- Personal history of colonic polyp or family history of colonic polyposis
- Known insulin-dependent or non-insulin-dependent diabetes
- Cardiovascular disease, left ventricular hypertrophy from other aetiology, recent
auricular or ventricular arrhythmia, history of vascularisation by aortocoronary
bypass significative mitral or aortic valvular disease, preexcitation syndrome,
auriculoventricular conduction delay, bradycardia-tachycardia syndrome, left
ventricular mass interfering treatment
- BMI (Body Mass Index) at least 30
- Growth hormone treatment during the 24 months prior to inclusion, history of treatment
with extractive pituitary growth hormone, allergy or suspected allergy to somatropin
therapy
- Patient who has participated in a different clinical study within the past two months
- Any condition which, in the opinion of the Investigator or the Scientific Committee,
may interfere with successful implementation of the study
- Notion of breast cancer for the mother or the sister
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
All
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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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Drug: placebo
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Primary Outcome(s)
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Left ventricular mass measured with ultrasonography
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Secondary Outcome(s)
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IGF-I (Insulin-Like Growth Factor I) concentration
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Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry)
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Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales
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Ventricular function indices assessed by cardiac ultrasonography
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Secondary ID(s)
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GHDADULT/F/1/F
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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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