Phase II Study of Growth Hormone in Children With Cystic Fibrosis
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT00016445
- Lead Sponsor
- University of Utah
- Brief Summary
OBJECTIVES: I. Determine the effect of growth hormone on height, height velocity, body weight, and lean body mass in patients with cystic fibrosis.
II. Determine the effect of growth hormone on pulmonary function in these patients.
III. Determine the impact of this drug on the quality of life in these patients.
IV. Determine if the clinical response from this drug is sustained in these patients.
- Detailed Description
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive growth hormone subcutaneously (SC) daily for 1 year during the first year only.
Arm II: Patients receive growth hormone SC daily for 1 year during the second year only.
Quality of life is assessed at baseline and then every 6 months for 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
T.L. Carey, M.D. and Associates
🇺🇸Tulsa, Oklahoma, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Southwest Medical Center at Dallas
🇺🇸Dallas, Texas, United States
James Whitcomb Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States