A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT00079742|
Recruitment Status : Completed
First Posted : March 16, 2004
Last Update Posted : June 9, 2008
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: Nutropin AQ [somatropin (DNA origin) injection]||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Official Title:||A Phase II, Multicenter, Randomized, Controlled, Open-Label Study of the Safety and Efficacy of Nutropin AQ [Somatropin (DNA Origin) Injection] for the Treatment of Growth Restriction in Children With Cystic Fibrosis|
|Study Start Date :||September 2003|
|Actual Study Completion Date :||May 2007|
- To determine the safety and efficacy of Nutropin AQ in treating growth restriction and increasing lean body mass (LBM) in children with cystic fibrosis (CF) and growth restriction.
- To evaluate the effects of Nutropin AQ treatment on pulmonary function, disease-related exacerbations, and exercise tolerance in children with CF and growth restriction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079742
|Study Director:||Barbara Lippe, M.D.||Genentech, Inc.|