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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01060488
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : August 5, 2014
Sponsor:
Information provided by:
Merck KGaA, Darmstadt, Germany

Tracking Information
First Submitted Date  ICMJE January 29, 2010
First Posted Date  ICMJE February 2, 2010
Last Update Posted Date August 5, 2014
Study Start Date  ICMJE January 2004
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2010)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2010)
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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency
Official Title  ICMJE 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)
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Growth Hormone Deficiency
Intervention  ICMJE
  • Other: GHRH+Arg, GHRH+Arg, ITT
    GHRH+Arg repeatability test (2 tests) + comparison with one IT test
  • Other: ITT, ITT, GHRH+Arg.
    IT repeatability test (2 tests) + comparison with one GHRH+Arg test
Study Arms  ICMJE
  • Active Comparator: Group 1:
    Intervention: Other: GHRH+Arg, GHRH+Arg, ITT
  • Active Comparator: Group 2:
    Intervention: Other: ITT, ITT, GHRH+Arg.
Publications * Chanson P, Cailleux-Bounacer A, Kuhn JM, Weryha G, Chabre O, Borson-Chazot F, Dubois S, Vincent-Dejean C, Brue T, Fedou C, Bresson JL, Demolis P, Souberbielle JC. Comparative validation of the growth hormone-releasing hormone and arginine test for the diagnosis of adult growth hormone deficiency using a growth hormone assay conforming to recent international recommendations. J Clin Endocrinol Metab. 2010 Aug;95(8):3684-92. doi: 10.1210/jc.2010-0295. Epub 2010 May 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2010)
69
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects aged over 18 years and under 60 years,
  • Female or male,
  • Subjects not treated by GH or having stopped the treatment more than 15 days ago,
  • Effective contraception in women of childbearing age: hormonal contraception or use of female condom and spermicides or use of diaphragm and spermicides or Intra Uterine Device (IUD),
  • Signed informed consent,
  • Subjects possessing social security cover.
  • Subjects having at least one of the following criteria were considered as subjects with a high probability of presenting a GH deficit:

    • Subjects with a tumour of the hypothalamo-hypophyseal region (hypophyseal adenomata, craniopharyngioma, meningioma, etc.) in whom the presence of a hypophyseal insufficiency in GH must be tested preoperatively or postoperatively, or
    • Subjects presenting a secondary ante-hypophyseal insufficiency to an inflammatory, infectious, post-traumatic pathology or to a hypophyseal necrosis, whose hypophyseal functional condition has already been documented and for whom a revaluation of GH secretion is desired, or
    • Subjects having undergone, as adults, an irradiation hypothalamo-hypophyseal region, or a suprasellar irradiation, in a clinical context of GH deficit, or
    • Subjects with a known organic ante-hypophyseal insufficiency beginning in childhood and with at least 1 associated deficit excluding prolactin.
  • Subjects having at least one of the following criteria were considered as subjects with a low probability of presenting a GH deficit:

    • Subjects with known idiopathic isolated GH deficit starting in childhood and for whom a new growth hormone secretion test is desired, or
    • Subjects with non-operated microadenoma (< 1 cm of diameter), or
    • Subjects with fortuitously discovered intrasellar image (e.g. Rathke's pocket cyst).

The third category of subjects eligible was made of healthy volunteers.

Exclusion Criteria:

  • Subjects presenting a coronary history or whose electrocardiographic signs evoke an ischemic pathology,
  • Subjects presenting a history of cerebrovascular insufficiency,
  • Subjects presenting a history of epilepsy,
  • Subjects with an evolutive acromegalia or an evolutive Cushing's syndrome,
  • Subjects presenting a known intolerance to arginine, GHRH or insulin,
  • Hyperkalemic subjects,
  • Diabetic subjects (Type 1 or Type 2),
  • Very obese subjects (BMI > 40),
  • Subjects presenting a severe, hepatic, renal, tumoral evolutive affection or metabolic or respiratory acidosis,
  • Subjects with known immuno-depression,
  • Subjects with psychiatric disorders,
  • Subjects presenting Parkinson's disease or Parkinsonian syndromes treated by Levodopa®,
  • Subjects treated by drugs directly affecting the hypophyseal secretion of somatotrophin (e.g. clonidine, levodopa) or provoking the release of somatostatin, antimuscarinic agents (atropine),
  • Subjects with untreated hypothyroidism or subjects treated by anti-thyroid synthesis drugs,
  • Participation in another biomedical research programme less than 3 months previously,
  • Known evolutive pregnancy or breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01060488
Other Study ID Numbers  ICMJE IMP24689
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Laurence Fresneau, Merck Serono s.a.s., an Affiliate of Merck KGaA, Darmstadt, Germany
Study Sponsor  ICMJE Merck KGaA, Darmstadt, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe Chanson, MD, Professor CHU Bicêtre, Endocrinology and Reproductive Diseases Department
PRS Account Merck KGaA, Darmstadt, Germany
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP