Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00174278
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Duration (Months): 115.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

To assess the effect of long-term treatment by Genotonorm on linear growth

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Deficiency; Growth Retardation	Drug: Somatropin	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety.
• Study Start Date: Feb 1, 1997
• Actual Study Completion Date: Oct 1, 2006

Outcome Measures

Primary Outcome Measures

1. The main efficacy variable is the height SDS (SEMPE) before and after treatment. []

2. The standing height of the patients is measured during the inclusion visit and at each follow-up visit. []

3. The height measurements are always performed at the same time of the day by []

4. use of a wallmounted device (e.g. Harpenden Stadiometer). []

5. Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height. []

6. The body weight is measured by use of a balance scale. []

7. Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014

• All patients who have stopped during one year will be included if a signed written informed consent

Exclusion Criteria:

• Endocrine disease, except well substituted hypothyroidism

• Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Paris		France

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00174278
• Other Study ID Numbers: 96-8123-018; A6281217
• First Posted: Sep 15, 2005
• Last Update Posted: Aug 5, 2008
• Last Verified: Aug 1, 2008

• Additional relevant MeSH terms: Dwarfism

Study Results

No Results Posted as of Aug 5, 2008