|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
University of Utah |
|---|---|
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00016445 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis |
Drug: growth hormone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Estimated Enrollment: | 40 |
| 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.
Eligibility| Ages Eligible for Study: | 5 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Contacts and Locations| 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 | |
| Washington University | |
| 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 | |
| Cook Children's Medical Center - Fort Worth | |
| Fort Worth, Texas, United States, 76104 | |
| Southwest Medical Center at Dallas | |
| Dallas, Texas, United States, 75390 | |
| 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 |
More Information
| Study ID Numbers: | 199/15806, UUSOM-IRB-7797-00, GENENTECH-UUSOM-IRB-7797-00 |
| Study First Received: | May 6, 2001 |
| Last Updated: | September 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00016445 |
| Health Authority: | Unspecified |
|
cardiovascular and respiratory diseases cystic fibrosis disease-related problem/condition |
genetic diseases and dysmorphic syndromes quality of life rare disease |
|
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis Lung Diseases |
Respiration Disorders Rare Diseases Quality of Life Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
|
Pathologic Processes |
