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

GHDADULT/F/1/F

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.

1998-10-21

2002-12-01

2002-12-01

Completed

Early phase I

22

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}

2024-02-28