Clinical Trials Logo
  1. Home
  2. Growth Disorders
  3. NCT00174408
  4. Details
NCT00174408 Clinical Trial

Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age

Growth Disorders Clinical Trial

Official title:
Growth Hormone Treatment in Short Children Born Small for Date (Genotonorm)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00174408
Other study ID # 89-041
Secondary ID A6281048
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated May 1, 2007
Start date March 1990
Est. completion date February 2005

Study information
Verified date May 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments)

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date February 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 7 Years
Eligibility Inclusion Criteria:

- Birth length below -2 SD

- Height at start below - 2 Sd

Exclusion Criteria:

- Any endocrine or chronic disease

- Any known syndrome with short stature

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Genotropin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Height, height velocity
Secondary Side effects
See also
  Status Clinical Trial Phase
Completed NCT01376921 - To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Spain N/A
Completed NCT01400997 - Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Czech Republic N/A
Completed NCT05244785 - Health and Nutrition Survey on Shenzhen Children
Completed NCT00097539 - A Postmarketing Surveillance Program for Nutropin, Nutropin AQ, and Protropin Phase 4
Not yet recruiting NCT04576845 - The Effect of Early Childhood Cow's Milk Allergy Elimination Diet on Eating Behaviors, Nutrition, and Growth Status
Not yet recruiting NCT05056285 - Pattern of Growth and Characteristics of Down Syndrome Pediatrics Patients
Completed NCT01263457 - To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in the UK
Terminated NCT00330668 - Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency Phase 3
Completed NCT00378859 - The Effect of Milk and Meat on IGFs in Prepubertal Boys N/A
Not yet recruiting NCT05577130 - Growth Pattern and Characteristics of Cardiac Pediatric Patients
Recruiting NCT05033119 - PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics
Completed NCT01402999 - To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Hungary N/A
Completed NCT01267526 - A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Pediatric Subjects Using SAIZEN® Via Easypod™ Auto-injector for Growth Hormone Treatment N/A
Completed NCT00139451 - Nutrients and Hormones: Effects in Boys With Disordered Growth Phase 2
Terminated NCT03274973 - Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome
Completed NCT02015286 - To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Middle East N/A
Completed NCT01582334 - To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Argentina N/A
Completed NCT01439061 - To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy N/A
Completed NCT00125164 - Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency Phase 3
Recruiting NCT05829252 - Testing the Feasibility of a Novel Growth Monitoring Smartphone App