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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	13 November 2023
Main ID:	NCT00705172
Date of registration:	24/06/2008
Prospective Registration:	Yes
Primary sponsor:	Novo Nordisk A/S
Public title:	Retrospective Observational Study on Efficacy and Safety of Norditropin® in Children With Prader-Willi Syndrome
Scientific title:	Efficacy and Safety of Norditropin® (Somatropin) in Children With Prader-Willi Syndrome (PWS)
Date of first enrolment:	November 2008
Target sample size:	41
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/ct2/show/NCT00705172
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Denmark	Germany	Switzerland

Contacts

Name:	Global Clinical Registry (GCR, 1452)
Address:
Telephone:
Email:
Affiliation:	Novo Nordisk A/S

Key inclusion & exclusion criteria

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®

Age minimum: N/A
Age maximum: 15 Years
Gender: All

Health Condition(s) or Problem(s) studied

Genetic Disorder

Prader-Willi Syndrome

Intervention(s)

Drug: somatropin

Primary Outcome(s)

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 Outcome(s)

Change in body composition (DEXA, Bio impedance or stable isotope dilution) [Time Frame: at 12 months- and at last observation during Norditropin treatment]

Haematology [Time Frame: at 12 months- and at last observation during Norditropin treatment]

Adverse Events. [Time Frame: 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) [Time Frame: at 12 months- and at last observation during Norditropin treatment]

Height velocity (HV) and change in HV [Time Frame: at 12 months- and at last observation during Norditropin treatment]

Thyroid-stimulating hormone (TSH) and active form of free thyroxin [Time Frame: at 12 months- and at last observation during Norditropin treatment]

Insulin-Like Growth Factor-I (IGF-I) [Time Frame: at 12 months- and at last observation during Norditropin treatment]

Glycated Fraction of Haemoglobin (HbA1c) [Time Frame: at 12 months- and at last observation during Norditropin treatment]

Secondary ID(s)

GHLIQUID-1961

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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