Growth Hormone DeficiencyPhase 3NCT01060488
Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency
A Phase 3 study testing GHRH+Arg, GHRH+Arg, ITT and ITT, ITT, GHRH+Arg. in people with Growth Hormone Deficiency, run by Merck KGaA, Darmstadt, Germany at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- GHRH+Arg, GHRH+Arg, ITT and ITT, ITT, GHRH+Arg.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2004to Nov 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Bicêtre, Endocrinology and Reproductive Diseases Department
Le Kremlin-Bicêtre
About this study
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)
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.
Read the 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.
- Conditions
- Growth Hormone Deficiency
- Being tested
- GHRH+Arg, GHRH+Arg, ITT, ITT, ITT, GHRH+Arg.
- Keywords
- GH secretion tests, adverse effects, adult growth hormone deficiency, growth-hormone releasing hormone and arginine test, insulin tolerance test, GHRH + Arginine test
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GHRH+Arg, GHRH+Arg, ITTOther
GHRH+Arg repeatability test (2 tests) + comparison with one IT test
ITT, ITT, GHRH+Arg.Other
IT repeatability test (2 tests) + comparison with one GHRH+Arg test
| Study group | Role | What they receive |
|---|---|---|
| Group 1: | Active comparator | Not described Receives: Other: GHRH+Arg, GHRH+Arg, ITT |
| Group 2: | Active comparator | Not described Receives: Other: ITT, ITT, GHRH+Arg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of GH peak (recorded following stimulation tests)
Measured: within 120 min after stimulation (blood samples were tacken at T0(before), T15, T30, T45, T60, T90 and T120 min after stimulation).
Secondary outcomes (1)
It was asked to the patients to evaluate acceptability of each test via a visual analogic scale.
Measured: After each test and before leaving the hospital (the day of the test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startJan 2004
- Primary completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philippe Chanson, MD, Professor, Principal investigator, CHU Bicêtre, Endocrinology and Reproductive Diseases Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060488
- Sponsor's protocol ID
- IMP24689
- Status last verified
- Jul 2011
- First submitted
- 29 Jan 2010
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20484474
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01060488
- Acronym / sponsor ID
- IMP24689
- Conditions
- Growth Hormone Deficiency
- Keywords
- GH secretion tests, adverse effects, adult growth hormone deficiency, growth-hormone releasing hormone and arginine test, insulin tolerance test, GHRH + Arginine test
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Nov 2005 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: | Active comparator | Other: GHRH+Arg, GHRH+Arg, ITT |
| Group 2: | Active comparator | Other: ITT, ITT, GHRH+Arg. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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,
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GHRH+Arg, GHRH+Arg, ITTGHRH+Arg repeatability test (2 tests) + comparison with one IT test | Other | Group 1: |
| ITT, ITT, GHRH+Arg.IT repeatability test (2 tests) + comparison with one GHRH+Arg test | Other | Group 2: |
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).
1 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
- Results publication: PubMed 20484474Chanson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Chanson, MD, Professor principal investigator
CHU Bicêtre, Endocrinology and Reproductive Diseases Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GHRH+Arg, GHRH+Arg, ITT and ITT, ITT, GHRH+Arg. in people with Growth Hormone Deficiency, run by Merck KGaA, Darmstadt, Germany at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01060488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014; AzTrials last refreshed its copy on 8 Nov 2026.