Adult Growth Hormone Deficiency Clinical Trial
Official title:
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
Verified date | February 2024 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.
Status | Completed |
Enrollment | 22 |
Est. completion date | December 1, 2002 |
Est. primary completion date | December 1, 2002 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Novo Nordisk Investigational Site | ANGERS cedex 09 | |
France | Novo Nordisk Investigational Site | Boisguillaume | |
France | Novo Nordisk Investigational Site | Brest | |
France | Novo Nordisk Investigational Site | Caen | |
France | Novo Nordisk Investigational Site | Grenoble | |
France | Novo Nordisk Investigational Site | Le Kremlin-bicetre | |
France | Novo Nordisk Investigational Site | Lille | |
France | Novo Nordisk Investigational Site | Lorient | |
France | Novo Nordisk Investigational Site | Lyon | |
France | Novo Nordisk Investigational Site | Lyon | |
France | Novo Nordisk Investigational Site | MARSEILLE Cédex 05 | |
France | Novo Nordisk Investigational Site | MONTPELLIER cedex 5 | |
France | Novo Nordisk Investigational Site | Nantes | |
France | Novo Nordisk Investigational Site | Nantes | |
France | Novo Nordisk Investigational Site | Nice | |
France | Novo Nordisk Investigational Site | Paris | |
France | Novo Nordisk Investigational Site | Paris | |
France | Novo Nordisk Investigational Site | Paris | |
France | Novo Nordisk Investigational Site | Reims | |
France | Novo Nordisk Investigational Site | Rennes | |
France | Novo Nordisk Investigational Site | Strasbourg | |
France | Novo Nordisk Investigational Site | TOULOUSE cedex | |
France | Novo Nordisk Investigational Site | Tours | |
France | Novo Nordisk Investigational Site | Vandoeuvre Les Nancy |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left ventricular mass measured with ultrasonography | |||
Secondary | Ventricular function indices assessed by cardiac ultrasonography | |||
Secondary | Bone mineral density and body composition assessed by DEXA (Dual Energy X-Ray Absorptiometry) | |||
Secondary | Quality of life using EQ5D (European Quality of Life 5 Dimensions) scales | |||
Secondary | IGF-I (Insulin-Like Growth Factor I) concentration |
Status | Clinical Trial | Phase | |
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