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GHRH+Arg, GHRH+Arg, ITT, ITT, ITT, GHRH+Arg

Phase 3

Growth Hormone Deficiency | Unknown | Endocrine |Merck KGaA|Last Updated: Aug 5, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment69

FDA Designations

No designations recorded

Clinical trial landscape

GHRH+Arg, GHRH+Arg, ITT, ITT, ITT, GHRH+Arg · 1 trial · 1 indication

Phase 3 1
NCT01060488Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone DeficiencyGrowth Hormone Deficiency
COMPLETED69 Analytics
PHASE3COMPLETED
Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency
Growth Hormone Deficiency
NCT0106048869
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Study Endpoints

Primary Endpoints

Level of GH peak (recorded following stimulation tests)
within 120 min after stimulation (blood samples were tacken at T0(before), T15, T30, T45, T60, T90 and T120 min after stimulation).

Secondary Endpoints

It was asked to the patients to evaluate acceptability of each test via a visual analogic scale.
After each test and before leaving the hospital (the day of the test)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Group 1:ACTIVE_COMPARATOR -
Group 2:ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
GHRH+Arg, GHRH+Arg, ITTOTHERGHRH+Arg repeatability test (2 tests) + comparison with one IT test
ITT, ITT, GHRH+Arg.OTHERIT repeatability test (2 tests) + comparison with one GHRH+Arg test
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 o...

Countries:France
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Frequently asked questions about GHRH+Arg, GHRH+Arg, ITT, ITT, ITT, GHRH+Arg

What is GHRH+Arg used for in Growth Hormone Deficiency?

GHRH+Arg is a diagnostic test used to evaluate Growth Hormone Deficiency in adults. It combines growth hormone releasing hormone with arginine to stimulate the pituitary gland to release growth hormone, allowing clinicians to assess whether a patient has a deficiency. The test was studied in a Phase 3 clinical trial in France.

Who makes GHRH+Arg?

GHRH+Arg is developed by Merck KGaA, a science and technology company. The company's stock is traded under the ticker MKGAF. Merck KGaA conducted a Phase 3 clinical trial to validate the GHRH+Arg test for diagnosing adult Growth Hormone Deficiency.

What phase is GHRH+Arg in?

GHRH+Arg is in Phase 3 clinical development. A Phase 3 trial, NCT01060488, has been completed. The trial was a comparative validation study for the diagnosis of adult Growth Hormone Deficiency. The drug is investigational and not yet approved for use.

What clinical trials is GHRH+Arg in?

GHRH+Arg has one completed Phase 3 clinical trial, NCT01060488, titled 'Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency.' The trial enrolled 69 participants in France and was active-controlled, meaning it compared GHRH+Arg against an existing diagnostic approach.

Is GHRH+Arg the same as the growth hormone releasing hormone and arginine test?

Yes, GHRH+Arg refers to the combination of growth hormone releasing hormone (GHRH) and arginine used as a diagnostic test. The clinical trial NCT01060488 specifically evaluated this combination for diagnosing adult Growth Hormone Deficiency. The test is designed to stimulate growth hormone secretion to identify deficient patients.