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Safety and Efficacy Study of Nutropin AQ to Treat Growth Restriction in Children with Cystic Fibrosis Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Safety and Efficacy Study of Nutropin AQ to Treat Growth Restriction in Children with Cystic Fibrosis conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety and Efficacy Study of Nutropin AQ to Treat Growth Restriction in Children with Cystic Fibrosis Clinical research trials and Safety and Efficacy Study of Nutropin AQ to Treat Growth Restriction in Children with Cystic Fibrosis healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Safety and Efficacy Study of Nutropin AQ to Treat Growth Restriction in Children with Cystic Fibrosis. Safety and Efficacy Study of Nutropin AQ to Treat Growth Restriction in Children with Cystic Fibrosis Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Safety and Efficacy Study of Nutropin AQ to Treat Growth Restriction in Children with Cystic Fibrosis clinical trial. Participants typically obtain the most effective healthcare available for their Safety and Efficacy Study of Nutropin AQ to Treat Growth Restriction in Children with Cystic Fibrosis condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.

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Safety and Efficacy Study of Nutropin AQ to Treat Growth Restriction in Children with Cystic Fibrosis



Safety and Efficacy Study of Nutropin AQ to Treat Growth Restriction in Children with Cystic Fibrosis

For Condition: Cystic Fibrosis
Status: Recruiting
Sponsor(s): Genentech ,
Synopsis: The purpose of this study is to evaluate the safety and efficacy of Nutropin AQ in treating growth restriction and increase lean body mass in children with Cystic Fibrosis (CF) and growth restriction.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 5 Years/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Subjects must meet the following criteria to be eligible for study entry: - Between the ages of 5 and 12 years old. - Diagnosis of Cystic Fibrosis by sweat or genetic testing. - Height <5th percentile for age and sex. - Ability to perform pulmonary function tests in a reproducible manner, per American Thoracic Society guidelines for spirometry. - Prepubertal, Tanner Stage 1. - Bone age of the non-dominant hand and wrist obtained no more than 6 months prior to study entry. Bone age must be <10 years for girls and <11 years for boys as read using the method of Greulich and Pyle. - Adequate caloric intake, based on the CFF guidelines. Caloric intake must be documented at screening or baseline using a 24-hour food diary. Exclusion Criteria: Subjects who meet any of the following criteria will be ineligible for study entry: - Prior or current rhGH use. - History of short stature due to GHD. - History of glucose intolerance or CF-related diabetes. - Use of any investigational drug within 30 days of study enrollment. - Infection with Burkholderia cepacia. - Qualitative change in antibiotic treatment (e.g., for exacerbation of lung infection) within 14 days of study entry. - Hospitalization or treatment with systemic corticosteroids during the 30 days prior to study entry. - Inability to adhere to previously documented adequate nutrition. - Active neoplasia. Intracranial lesions must be inactive and anti-tumor therapy completed at least 1 year prior to the baseline evaluation. - Use of any investigational drug within 30 days of study enrollment.
Total Enrollment: 100

Location and Contact Information:

Trial Information Support Center (TISL) *Recruiting*
Denver,  Colorado,  00000
United States
Recruiting Support  Staff 888-662-6728


Additional Information:
Study ID Numbers:  L2762g;  IND# 68,017
Study Start Date: January 2004
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079742

Other Cystic Fibrosis Studies:
1. Phase II Study of Growth Hormone in Children With Cystic Fibrosis

2. Phase II Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Mucoid Exopolysaccharide Pseudomonas Aeruginosa Immune Globulin for Cystic Fibrosis

3. Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

4. Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis

5. A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis

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