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Completed

NCT Number: NCT00174278

Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary

To assess the effect of long-term treatment by Genotonorm on linear growth

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Growth Retardation Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014
  • All patients who have stopped during one year will be included if a signed written informed consent

Exclusion criteria

  • Endocrine disease, except well substituted hypothyroidism
  • Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)

Treatment and study plan

Somatropin

Drug

Primary outcomes

  1. The main efficacy variable is the height SDS (SEMPE) before and after treatment.

  2. The standing height of the patients is measured during the inclusion visit and at each follow-up visit.

  3. The height measurements are always performed at the same time of the day by

  4. use of a wallmounted device (e.g. Harpenden Stadiometer).

  5. Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height.

  6. The body weight is measured by use of a balance scale.

  7. Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety.

Important dates

Study start
1997
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Aug 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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