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NCT00567385 Clinical Trial

Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

Growth Hormone Disorder Clinical Trial

Official title:
An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00567385
Other study ID # GHLIQUID-1515
Secondary ID
Status Completed
Phase Phase 4
First received November 30, 2007
Last updated February 27, 2017
Start date March 10, 2003
Est. completion date March 22, 2004

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 176
Est. completion date March 22, 2004
Est. primary completion date March 22, 2004
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin

Locations
Country Name City State
Turkey Novo Nordisk Investigational Site Altunizade-Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of acceptance after 12 weeks of treatment
Secondary Safety
Secondary Adverse Events (AE)
Secondary Compliance
See also
  Status Clinical Trial Phase
Completed NCT02229851 - Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. Phase 3
Completed NCT01563926 - Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency Phase 3
Completed NCT01562834 - Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients Phase 4
Completed NCT01109017 - Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency N/A
Completed NCT01706783 - A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency Phase 1
Completed NCT01245374 - Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents Phase 4
Completed NCT00184730 - Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) Phase 3
Completed NCT01502124 - Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency Phase 3
Completed NCT00519558 - Growth Hormone Deficiency in Adults (GHDA) Phase 3
Completed NCT01604161 - Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome N/A
Completed NCT00102817 - Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children Phase 3
Terminated NCT01698944 - Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency Phase 4
Completed NCT03075644 - A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency Phase 3
Recruiting NCT02616562 - Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency Phase 2
Completed NCT02005198 - Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) N/A
Completed NCT01009905 - An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone) N/A
Completed NCT03186495 - Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function Phase 1
Completed NCT00934063 - An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® N/A
Completed NCT00715689 - Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Phase 2
Completed NCT00722540 - Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Phase 1

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