Clinical Trial: Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 The randomisation was carried out before the first test was performed. In order to be informed of the subject's randomisation group, the investigator phoned the access number given to him/her. The subject's 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: GHRH+Arg, GHRH+Arg, ITT or
  • Group 2: ITT, ITT, GHRH+Arg.

Sponsor: Merck KGaA

Current Primary Outcome: Level of GH peak (recorded following stimulation tests) [ Time Frame: within 120 min after stimulation (blood samples were tacken at T0(before), T15, T30, T45, T60, T90 and T120 min after stimulation). ]

Original Primary Outcome: Same as current

Current Secondary Outcome: It was asked to the patients to evaluate acceptability of each test via a visual analogic scale. [ Time Frame: After each test and before leaving the hospital (the day of the test) ]

Original Secondary Outcome: Same as current

Information By: Merck KGaA

Dates:
Date Received: January 29, 2010
Date Started: January 2004
Date Completion:
Last Updated: August 4, 2014
Last Verified: July 2011