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Clinical Trials/NCT00705172
NCT00705172CompletedNot Applicable

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

Novo Nordisk A/S0 sites41 target enrollmentStarted: November 2008Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
41
Primary Endpoint
Primary objective is to investigate changes in height Standard Deviation Score (SDS)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Ages
— to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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®

Arms & Interventions

A

Intervention: somatropin (Drug)

Outcomes

Primary Outcomes

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

  • Glycated Fraction of Haemoglobin (HbA1c)(at 12 months- and at last observation during Norditropin treatment)
  • Changes in height SDS from start of treatment to last observation during Norditropin treatment (referenced to PWS population1)(at 12 months- and at last observation during Norditropin treatment)
  • Haematology(at 12 months- and at last observation during Norditropin treatment)
  • Change in body composition (DEXA, Bio impedance or stable isotope dilution)(at 12 months- and at last observation during Norditropin treatment)
  • Height velocity (HV) and change in HV(at 12 months- and at last observation during Norditropin treatment)
  • Adverse Events.(at 12 months- and at last observation during Norditropin treatment)
  • Insulin-Like Growth Factor-I (IGF-I)(at 12 months- and at last observation during Norditropin treatment)
  • Thyroid-stimulating hormone (TSH) and active form of free thyroxin(at 12 months- and at last observation during Norditropin treatment)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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