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NCT00016445 Clinical Trial

Phase II Study of Growth Hormone in Children With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00016445
Other study ID # 199/15806
Secondary ID UUSOM-IRB-7797-0
Status Completed
Phase Phase 2
First received May 6, 2001
Last updated September 8, 2008
Start date February 2001

Study information
Verified date September 2008
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 12 Years
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• growth hormone

Locations
Country Name City State
United States Southwest Medical Center at Dallas Dallas Texas
United States Children's Medical Center - Dayton Dayton Ohio
United States Cook Children's Medical Center - Fort Worth Fort Worth Texas
United States James Whitcomb Riley Hospital for Children Indianapolis Indiana
United States Children's Hospital of Orange County Orange California
United States Phoenix Children's Hospital Phoenix Arizona
United States Washington University Saint Louis Missouri
United States Primary Children's Medical Center Salt Lake City Utah
United States T.L. Carey, M.D. and Associates Tulsa Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

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