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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:	21 August 2023
Main ID:	NCT01529944
Date of registration:	02/01/2012
Prospective Registration:	No
Primary sponsor:	Novo Nordisk A/S
Public title:	Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658
Scientific title:	Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 Trial
Date of first enrolment:	September 2008
Target sample size:	22
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/ct2/show/NCT01529944
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment
Sweden

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participation in the GHNOO-1658 trial

- Subject has completed genetic testing of PTPN11 mutation

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

Health Condition(s) or Problem(s) studied

Genetic Disorder

Noonan Syndrome

Intervention(s)

Drug: somatropin

Primary Outcome(s)

Change in height SDS (Standard Deviation Score) (referenced to normal population) [Time Frame: From baseline until final height is reached]

Secondary Outcome(s)

Final height SDS (referenced to Noonan population) [Time Frame: From baseline until final height is reached]

Final height SDS (referenced to normal population) [Time Frame: From baseline until final height is reached]

Adverse events [Time Frame: From baseline until final height is reached]

Proportion of subjects with final height SDS above - 2SDS (reference to normal population) [Time Frame: When final height is reached]

Number of subjects with final height SDS above - 2SDS (reference to normal population) [Time Frame: When final height is reached]

Change in height SDS (referenced to Noonan population) [Time Frame: From baseline until final height is reached]

Secondary ID(s)

2008-004535-38

GHNOO-3680

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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