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| Sponsor: | Genentech |
|---|---|
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00079742 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis |
Drug: Nutropin AQ [somatropin (DNA origin) injection] |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
| Enrollment: | 68 |
| Study Start Date: | September 2003 |
| Study Completion Date: | May 2007 |
Eligibility| Ages Eligible for Study: | 5 Years to 13 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | L2762g |
| Study First Received: | March 11, 2004 |
| Last Updated: | June 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00079742 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Growth restriction in children with cystic fibrosis |
|
Pathologic Processes Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases |