Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00567385
• Collaborator: (none)
• Enrollment: 176
• Location: 1
• Actual Duration (Months): 12.4
• Patients Per Site Per Month: 14.2

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency.

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Disorder; Growth Hormone Deficiency in Children	Drug: somatropin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 176 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency
• Actual Study Start Date: Mar 10, 2003
• Actual Primary Completion Date: Mar 22, 2004
• Actual Study Completion Date: Mar 22, 2004

Outcome Measures

Primary Outcome Measures

1. Assessment of acceptance [after 12 weeks of treatment]

Secondary Outcome Measures

1. Safety []

2. Adverse Events (AE) []

3. Compliance []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Growth failure due to growth hormone insufficiency (GHD)

• Turner syndrome: established diagnosis according to sex chromosome analysis, or

• Growth retardation in children with chronic renal disorders

Exclusion Criteria:

• Pregnancy

• Breast feeding women

• Suspected or know allergy to trial product

• Participating in any other trial involving other investigational products within the last 3 months

• Previous participation in the trial

• Other daily injection therapy (non-growth hormone, e.g insulin-therapy)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Altunizade-Istanbul		Turkey	34662

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT00567385
• Other Study ID Numbers: GHLIQUID-1515
• First Posted: Dec 4, 2007
• Last Update Posted: Feb 28, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Dwarfism, Pituitary

Study Results

No Results Posted as of Feb 28, 2017