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Phase II Study of Growth Hormone in Children With Cystic Fibrosis Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Phase II Study of Growth Hormone in Children With Cystic Fibrosis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase II Study of Growth Hormone in Children With Cystic Fibrosis Clinical research trials and Phase II Study of Growth Hormone in Children With Cystic Fibrosis medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Phase II Study of Growth Hormone in Children With Cystic Fibrosis. Phase II Study of Growth Hormone in Children With Cystic Fibrosis Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Phase II Study of Growth Hormone in Children With Cystic Fibrosis clinical trial. Participants frequently get the best healthcare available for their Phase II Study of Growth Hormone in Children With Cystic Fibrosis condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase II Study of Growth Hormone in Children With Cystic Fibrosis  Phase II Study of Growth Hormone in Children With Cystic Fibrosis
Phase II Study of Growth Hormone in Children With Cystic Fibrosis
For Condition: Cystic Fibrosis
Status: Recruiting
Sponsor(s): University of Utah ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 5 Years/12 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 40
Location and Contact Information:
Overall Study Official:
DanaHardin, Study Chair, University of Utah
James Whitcomb Riley Hospital for Children *Recruiting*
Indianapolis, Indiana, 46202-5225
United States
Recruiting Michelle Howenstine 317-274-7208
Cook Children's Medical Center - Fort Worth *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting Maynard Dyson 817-810-1621
University of Utah School of Medicine *Recruiting*
Salt Lake City, Utah, 84132
United States
Recruiting Dana Hardin 801-585-3485
Children's Hospital of Orange County *Recruiting*
Orange, California, 92868
United States
Recruiting Phillip Lee 714-532-8634
Primary Children's Medical Center *Recruiting*
Salt Lake City, Utah, 84113
United States
Recruiting Barbara Chatfield 801-588-2621
T.L. Carey, M.D. and Associates *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting John Kramer 918-481-8100
Phoenix Children's Hospital *Recruiting*
Phoenix, Arizona, 85006
United States
Recruiting Peggy Radford 602-239-5778
Washington University *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Ross Shepherd 314-454-2337
Children's Medical Center - Dayton *Recruiting*
Dayton, Ohio, 45404
United States
Recruiting Dennis Nielson 937-226-8440
Additional Information:
Study ID Numbers: 199/15806; UUSOM-IRB-7797-00,GENENTECH-UUSOM-IRB-7797-00
Study Start Date: February 2001
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016445
Other Cystic Fibrosis Studies:
1. Studying Patients with Cystic Fibrosis and Other Pulmonary and Pancreatic Disorders
2. Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis
3. Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease
4. Interferon gamma-1b by inhalation for the treatment of patients with cystic fibrosis
5. Role of Genetic Factors in the Development of Lung Disease
Related Studies:
Other Cystic Fibrosis Clinical Trials
Other Ohio Clinical Trials
Other Dayton Clinical Trials
Phase II Study of Growth Hormone in Children With Cystic Fibrosis
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