Phase II Study of Growth Hormone in Children With Cystic Fibrosis
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.
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||February 2001|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
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.
|United States, Arizona|
|Phoenix Children's Hospital|
|Phoenix, Arizona, United States, 85006|
|United States, California|
|Children's Hospital of Orange County|
|Orange, California, United States, 92868|
|United States, Indiana|
|James Whitcomb Riley Hospital for Children|
|Indianapolis, Indiana, United States, 46202-5225|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|Children's Medical Center - Dayton|
|Dayton, Ohio, United States, 45404|
|United States, Oklahoma|
|T.L. Carey, M.D. and Associates|
|Tulsa, Oklahoma, United States, 74136|
|United States, Texas|
|Southwest Medical Center at Dallas|
|Dallas, Texas, United States, 75390|
|Cook Children's Medical Center - Fort Worth|
|Fort Worth, Texas, United States, 76104|
|United States, Utah|
|Primary Children's Medical Center|
|Salt Lake City, Utah, United States, 84113|
|Study Chair:||Dana S. Hardin||Southwest Medical Center at Dallas|