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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 is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Safety and Efficacy Study of Nutropin AQ to Treat Growth Restriction in Children with Cystic Fibrosis conditions. Clinical Trials Search.org is a site devoted 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 medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like 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 for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated 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. Test subjects typically obtain the finest 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, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict 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. Bone Health of People with Cystic Fibrosis

2. Tissue Collection from People with Cystic Fibrosis

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

4. Study of Mycobacterial Infections

5. A multi-centered study of the long-term effect of salmeterol and albuterol in cystic fibrosis

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