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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01697644
Other study ID # GHRETARD/NL/21
Secondary ID
Status Completed
Phase Phase 4
First received September 28, 2012
Last updated January 17, 2017
Start date October 1990
Est. completion date May 2005

Study information

Verified date January 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 assess and compare the efficacy and safety of two dose levels of somatropin over a long period (till final height is reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial) and GHRETARD/BPD/20/NL (a 2-year extension trial).


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date May 2005
Est. primary completion date May 2005
Accepts healthy volunteers No
Gender All
Age group 3 Years to 11 Years
Eligibility Inclusion Criteria:

- Completion of the GHRETARD/BPD/20/NL trial

- Written informed consent from child and/or parents/guardians before continuation in the extension trial

Study Design


Intervention

Drug:
somatropin
3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily
somatropin
3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily

Locations

Country Name City State
Netherlands Novo Nordisk Investigational Site Rotterdam
Netherlands Novo Nordisk Investigational Site Rotterdam

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

Boonstra V, van Pareren Y, Mulder P, Hokken-Koelega A. Puberty in growth hormone-treated children born small for gestational age (SGA). J Clin Endocrinol Metab. 2003 Dec;88(12):5753-8. — View Citation

Sas T, de Waal W, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Growth hormone treatment in children with short stature born small for gestational age: 5-year results of a randomized, double-blind, dose-response trial. J Clin Endocrinol Metab — View Citation

Sas T, Mulder P, Aanstoot HJ, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Carbohydrate metabolism during long-term growth hormone treatment in children with short stature born small for gestational age. Clin Endocrinol (Oxf). 2001 Feb;54(2):243-51. — View Citation

Sas T, Mulder P, Hokken-Koelega A. Body composition, blood pressure, and lipid metabolism before and during long-term growth hormone (GH) treatment in children with short stature born small for gestational age either with or without GH deficiency. J Clin — View Citation

Sas TC, Gerver WJ, De Bruin R, Mulder PG, Cole TJ, De Waal W, Hokken-Koelega AC. Body proportions during 6 years of GH treatment in children with short stature born small for gestational age participating in a randomised, double-blind, dose-response trial — View Citation

Van Pareren Y, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Adult height after long-term, continuous growth hormone (GH) treatment in short children born small for gestational age: results of a randomized, double-blind, dose-response GH tria — View Citation

van Pareren Y, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Effect of discontinuation of growth hormone treatment on risk factors for cardiovascular disease in adolescents born small for gestational age. J Clin Endocrinol Metab. 2003 Jan;88( — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Linear growth (height during childhood)
Primary Final height
Primary Bone maturation
Primary Pubertal development
Secondary Adverse events
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