Ignite Creation Date:
2024-05-05 @ 10:15 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01060488
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
2010-01-29
Brief Title:
Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency
Sponsor:
Merck KGaA Darmstadt Germany
Organization:
Merck KGaA Darmstadt Germany
Study Overview
Official Title:
A Phase III Multicentric Open-label Randomised Comparative Parallel Group Study of GHRH Arginine Combination Test vs Insulin Tolerance Test ITT in the Diagnosis of Adult Growth Hormone Deficiency AGHD
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to determine the specificity and sensitivity of the combined growth hormone releasing hormone GHRH Arginine test in healthy volunteers subjects with highly probable adult growth hormone deficiency AGHD and subjects who were probably free of AGHD
Detailed Description:
The randomisation was carried out before the first test was performed In order to be informed of the subjects randomisation group the investigator phoned the access number given to himher The subjects allocation to a given randomisation arm was determined on the basis of a centralised randomisation answering service balanced per group of subjects with a minimisation on 2 criteria age and BMI
This was a centralised randomisation using a Interactive Voice Response System IVRS which was balanced in each of the following 3 categories of subjects
Category A healthy volunteers
Category B subjects with a strong probability of deficit in GH
Category C subjects with a low probability of deficit in GH
In each of these 3 categories the subjects underwent 3 tests whose sequences were determined by the following randomisation group
Group 1 GHRHArg GHRHArg ITT or
Group 2 ITT ITT GHRHArg
This was a centralised randomisation using a Interactive Voice Response System IVRS which was balanced in each of the following 3 categories of subjects
Category A healthy volunteers
Category B subjects with a strong probability of deficit in GH
Category C subjects with a low probability of deficit in GH
In each of these 3 categories the subjects underwent 3 tests whose sequences were determined by the following randomisation group
Group 1 GHRHArg GHRHArg ITT or
Group 2 ITT ITT GHRHArg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None