Phase II Study of Growth Hormone in Children With Cystic Fibrosis - Full Text View

Sponsor:	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

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	40
Study Start Date:	February 2001
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	5 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016445

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

Sponsors and Collaborators

University of Utah

Investigators

Study Chair:

Dana S. Hardin

Southwest Medical Center at Dallas

More Information

No publications provided

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 History of Changes
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:

Fibrosis
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Digestive System Diseases
Pathologic Processes

Cystic Fibrosis
Respiratory Tract Diseases
Genetic Diseases, Inborn
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on November 22, 2009