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Completed

NCT Number: NCT00705172

Retrospective Observational Study on Efficacy and Safety of Norditropin® in Children With Prader-Willi Syndrome

This study is conducted in Europe. The aim of this observational study is to collect data from children with Prader-Willi Syndrome, who have been treated off-label with Norditropin® for more than 12 months to seek approval for Norditropin® treatment with Prader-Willi Syndrome.

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Key information

Conditions

Genetic Disorder Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Prader-Willi Syndrome

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arhus N, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent obtained before any trial-related activities
  • Genetically diagnosed Prader-Willi Syndrome
  • Received at least one dose of Norditropin® treatment
  • Pre-pubertal at start of treatment; assessed by Tanner stage 1, or testicular volume below 4ml (according to Tanner 1976)

Exclusion criteria

  • Pre-treatment with other Growth Hormone preparation prior to treatment with Norditropin®

Treatment and study plan

Somatropin

Drug

Prader-Willi syndrome children treated with at least one dose of Norditropin®

Other names: Norditropin®

Primary outcomes

  1. Primary objective is to investigate changes in height Standard Deviation Score (SDS)

    Time frame: in response to 12 months Norditropin® treatment in children with PWS (referenced to PWS population

Secondary outcomes

  1. Changes in height SDS from start of treatment to last observation during Norditropin treatment (referenced to PWS population1)

    Time frame: at 12 months- and at last observation during Norditropin treatment

  2. Change in body composition (DEXA, Bio impedance or stable isotope dilution)

    Time frame: at 12 months- and at last observation during Norditropin treatment

  3. Height velocity (HV) and change in HV

    Time frame: at 12 months- and at last observation during Norditropin treatment

  4. Glycated Fraction of Haemoglobin (HbA1c)

    Time frame: at 12 months- and at last observation during Norditropin treatment

  5. Insulin-Like Growth Factor-I (IGF-I)

    Time frame: at 12 months- and at last observation during Norditropin treatment

  6. Haematology

    Time frame: at 12 months- and at last observation during Norditropin treatment

  7. Thyroid-stimulating hormone (TSH) and active form of free thyroxin

    Time frame: at 12 months- and at last observation during Norditropin treatment

  8. Adverse Events.

    Time frame: at 12 months- and at last observation during Norditropin treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Norditropin® (Somatropin) in Children With Prader-Willi Syndrome (PWS)

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 25, 2008
Registry last updated
Nov 2, 2023

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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