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NCT01562834 Clinical Trial

Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01562834
Other study ID # GHDADULT/F/1/F
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 21, 1998
Est. completion date December 1, 2002

Study information
Verified date February 2024
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin
Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months (randomised trial period) followed by an 12-month open-label trial period with somatropin.
• placebo
Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months. After treatment in the randomised trial period, placebo will be discontinued.

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

Outcome
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
See also
  Status Clinical Trial Phase
Completed NCT02229851 - Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. Phase 3
Completed NCT01822340 - Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients Phase 2
Completed NCT01109017 - Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency N/A
Completed NCT01706783 - A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency Phase 1
Completed NCT00184730 - Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) Phase 3
Completed NCT00519558 - Growth Hormone Deficiency in Adults (GHDA) Phase 3
Terminated NCT01698944 - Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency Phase 4
Completed NCT03075644 - A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency Phase 3
Completed NCT02005198 - Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) N/A
Completed NCT01806298 - An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD) Phase 4
Terminated NCT01909479 - A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency Phase 3
Completed NCT03186495 - Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function Phase 1
Not yet recruiting NCT04867317 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD) Phase 3
Recruiting NCT05979480 - The Effects of Growth Hormone Treatment Discontinuation in Adults on Metabolic Profile, Body Composition and Quality Of Life (GAMBOL Study)
Completed NCT02526420 - Versartis International Trial in Adults With Long-Acting Growth Hormone Phase 2
Completed NCT00934063 - An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® N/A
Completed NCT00715689 - Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Phase 2
Completed NCT00297713 - Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety Phase 2
Completed NCT01543880 - Safety and Efficacy of Long-term Somatropin Treatment in Adults N/A
Completed NCT01580605 - French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin

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