Phase II Study of Growth Hormone in Children With Cystic Fibrosis
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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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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--
- Diagnosis of prepubertal cystic fibrosis
- No colonization by Burkholderia cepacia
--Prior/Concurrent Therapy--
- No prior or concurrent insulin requirement
--Patient Characteristics--
- Hematopoietic: No hematologic disease
- Hepatic: No liver disease
- Renal: No kidney disease
- Pulmonary: Must be able to perform pulmonary function testing
- Other: No history of diabetes Must be less than 25% of normal height and/or weight for age and sex
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 | |
| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00016445 History of Changes |
| Other 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 |
| Health Authority: | Unspecified |
Keywords provided by Office of Rare Diseases (ORD):
|
cardiovascular and respiratory diseases cystic fibrosis disease-related problem/condition |
genetic diseases and dysmorphic syndromes quality of life rare disease |
Additional relevant MeSH terms:
|
Cystic Fibrosis Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn |
Infant, Newborn, Diseases Pathologic Processes Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013