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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 11, 2004 | ||||
| Last Updated Date | June 5, 2008 | ||||
| Start Date ICMJE | September 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00079742 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To evaluate the effects of Nutropin AQ treatment on pulmonary function, disease-related exacerbations, and exercise tolerance in children with CF and growth restriction. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | This is a Phase II, multicenter, randomized, controlled, open-label trial of the safety and efficacy of Nutropin AQ administered subcutaneously (SC) daily in prepubertal children with CF and growth restriction. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Cystic Fibrosis | ||||
| Intervention ICMJE | Drug: Nutropin AQ [somatropin (DNA origin) injection] | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 68 | ||||
| Completion Date | May 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 13 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00079742 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | L2762g | ||||
| Study Sponsor ICMJE | Genentech | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Genentech | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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