Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
NCT ID: NCT00355030
Last Updated: 2019-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
91 participants
INTERVENTIONAL
2006-06-30
2015-07-31
Brief Summary
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Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with somatropin alone. Participants from France who participated in this Period 1 of the study were asked to participate in a long term safety follow up defined as a Period 2 of the study. Participants from the Netherlands were offered participation in Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov Identifier: NCT01088412) for long term safety follow up independent of this study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
somatropin
0.05 mg/kg/day
leuprorelin
11.25 mg/3 months
2
somatropin
0.05 mg/kg/day
Interventions
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somatropin
0.05 mg/kg/day
leuprorelin
11.25 mg/3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age greater than or equal to 8 years and less than or equal to 12 years and 3 months for girls and greater than or equal to 9 years and less than or equal to 14 years and 3 months for boys
* bone age less than or equal to 12.0 years for girls and less than or equal to 14.0 years for boys based on a central reading of an X-ray of the left hand and wrist
* Pubertal stage B2 and B3 for girls based on the Tanner method
* Pubertal stage G2 and G3 for boys based on the Tanner method
Exclusion Criteria
* Insulin-like growth factor-I levels greater than 3 SDS
* Chromosomal abnormality diagnosed locally on a karyotype. For girls, the karyotype to eliminate a Turner syndrome, is mandatory
* Small for gestational age (SGA)
* Has reached menarche (had her first menstrual period)
* Have any significant concomitant disease that is likely to interfere with growth or with the study, or is a known contraindication to Growth Hormone treatment
8 Years
171 Months
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Amiens, , France
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Besançon, , France
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Bordeaux, , France
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Boulogne, , France
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Le Havre, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Nice, , France
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Paris, , France
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Reims, , France
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Rennes, , France
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Rouen, , France
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Saint-Etienne, , France
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Strasbourg, , France
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Tarbes, , France
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Toulouse, , France
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
Countries
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Other Identifiers
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B9R-FP-GDGI
Identifier Type: OTHER
Identifier Source: secondary_id
9861
Identifier Type: -
Identifier Source: org_study_id
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