Phase II Study of Growth Hormone in Children With Cystic Fibrosis

University of Utah9 sites in 1 country40 target enrollmentFebruary 2001

ConditionsCystic Fibrosis

Drugsgrowth hormone

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Cystic Fibrosis
Sponsor: University of Utah
Enrollment: 40
Locations: 9
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

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.

Registry

clinicaltrials.gov

Start Date

February 2001

End Date

August 2007

Last Updated

17 years ago

Study Type

Interventional

Sex

All