A Study Investigating a New, Oral Growth Hormone Secretagogue (GHS)(ARD-07) as a Growth Hormone (GH) Stimulation Test - Full Text View

Purpose

The diagnosis of GH deficiency (GHD) in adults is established by laboratory testing in patients with an appropriate clinical history of hypothalamic pituitary disease. Two tests that are considered to be gold standard tests for the diagnosis of GHD are the insulin tolerance test (ITT) and GHRH combined with arginine. However, these tests are either bothersome (given intravenously) to the patient or are linked with side effects. Therefore, an orally available compound like ARD-07, if demonstrated to be safe and providing adequate sensitivity and specificity could be a welcome alternative and/or complement to the current available tests.

Condition	Intervention	Phase
Hypopituitarism Hypothalamic Disease	Drug: ARD-07	Phase II Phase III

MedlinePlus related topics:

Pituitary Disorders

Drug Information available for:

Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Official Title:	A Multi-Center, Randomized, Cross-Over Study Investigating a New, Oral Growth Hormone Secretagogue (GHS)(ARD-07) as a Growth Hormone (GH) Stimulation Test in Terms of Safety and Efficacy Compared to L-ARG+GHRH

Further study details as provided by Ardana Bioscience Ltd:

Primary Outcome Measures:

sensitivity
specificity
misclassification

Secondary Outcome Measures:

pharmacodynamic
patient preference
safety
tolerability

Estimated Enrollment:	80
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion:

GHD subjects:

• Confirmed GH deficiency

Matched Normal Controls:

Undergone normal growth and development
Normal serum PRL concentrations
Females should have a history of regular, age-appropriate menses
Males should have normal serum testosterone concentrations
Matched GHD subject already enrolled in study; matched in terms of sex; age; BMI; Estrogen status (women only)

Exclusion Criteria:

Untreated hypothyroidism
- Intracranial lesions stable for less than 6 months
- GH therapy within one month of study entry
- Active Cushings disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448747

Locations


United States, California
	Cedars-Sinai Medical Center
	Los Angeles, California, United States, 90048
	Stanford University
	Stanford, California, United States, 94305-5826
	Harbor-UCLA Medical Center
	Torrance, California, United States, 90502

United States, Illinois
	Northwestern University
	Chicago, Illinois, United States, 60611-3008

United States, Maryland
	Johns Hopkins University
	Baltimore, Maryland, United States, 21287

United States, Massachusetts
	Massachusetts General Hospital
	Boston, Massachusetts, United States, 02114

United States, Oregon
	Oregon Health and Science University
	Portland, Oregon, United States, 97239

United States, Texas
	dgd Research
	San Antonio, Texas, United States, 78229-4801
	Baylor College of Medicine
	Houston, Texas, United States, 77030

United States, Washington
	VA Puget Sound HCS
	Seattle, Washington, United States, 98493

Sponsors and Collaborators

Ardana Bioscience Ltd

Investigators


Principal Investigator:	Beverly MK Biller, MD	Massachusetts General Hospital, Boston

More Information

Responsible Party:	Ardana Bioscience Ltd. ( Ardana Bioscience Ltd. )
Study ID Numbers:	ARD-0705-001
First Received:	March 16, 2007
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00448747
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypothalamic Diseases

Pituitary Diseases

Hypopituitarism

Endocrine System Diseases

Central Nervous System Diseases

Endocrinopathy

Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Ardana Bioscience Ltd
Information provided by:	Ardana Bioscience Ltd
ClinicalTrials.gov Identifier:	NCT00448747