Growth Hormone DisorderNCT02005198
Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
An observational study of Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
This study is conducted in the United States of America (USA). The aim of the study is to assess the minimal important difference (MID) of the TRIM-AGHD. Read more about this study
- Who is it for?
- Ages 23 to 79 years
- Conditions the study is for
- Growth Hormone Disorder, Adult Growth Hormone Deficiency
- What is being tested?
- No treatment given
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2015
- Phase
- Observational
- 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 23 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a diagnosis of growth hormone deficiency (GHD), naïve to treatment currently and for at least 6 months prior, who are beginning a new prescription treatment for their GHD. Patients will be selected by sites as per inclusion and exclusion criteria
Who may be able to join
- Able to speak read and write English
- GHD (Growth Hormone Deficiency) treatment naïve which is defined as not being on a prescription treatment for their GHD currently and for at least 6 months
- Beginning a new prescription GHD treatment and expected to be on this treatment for GHD for a minimum of 6 months
- GHD of either one of the following criteria: a) Adult onset: subjects who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or traumatic brain injury (TBI), b) Childhood Onset: Subjects who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes
- Confirmed diagnosis of growth hormone deficiency (if a subject satisfies any one of the three following criteria): a) For the insulin tolerance test (ITT) or glucagon test both performed within the last five years: the validated cut-off for GHD in adults is a peak GH response of below 3.0 ng/mL (3 microg/L), b) For growth hormone releasing hormone (GHRH) +Arginine test performed within the last five years: for those subjects with a body mass index (BMI) below 25 kg/m^2, a peak GH below 11 ng/mL (microg /L); for BMI 25-30 kg/m^2, a peak GH below 8 ng/mL (8 microg/L); for BMI above 30 kg/m^2, a peak GH below 4 ng/mL 341 (4 microg/L ), c) Three or more pituitary hormone deficiencies at screening
- Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)
Who cannot join
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Patients who have been on a prescription medication for treatment of GHD in past 6 months
- Patients with a total Beck Depression Inventory II (BDI-II) score greater than 25
- Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
- Acute severe illness associated with weight loss in the last 6 months (defined as a loss of more than 5.0% total body weight)
- Active Cushings syndrome within the last 24 months
- Subject with overt diabetes mellitus
- Previous participation in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Princeton, New Jersey, 08540
About this study
This study is conducted in the United States of America (USA). The aim of the study is to assess the minimal important difference (MID) of the TRIM-AGHD.
- Being tested
- No treatment given
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
Subject will only fill out a questionnaire when entering the non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Survey | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in CGI (Clinician Global Impression Scale)
Measured: After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment
Changes in PGI (Patient Global Impression Scale)
Measured: After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005198
- Sponsor's protocol ID
- NN8640-4123
- Other IDs
- U1111-1146-1750
- Status last verified
- Jan 2017
- First submitted
- 3 Dec 2013
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
- ClinicalTrials.gov ID
- NCT02005198
- Acronym / sponsor ID
- NN8640-4123
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Dec 2013 (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.
This study is conducted in the United States of America (USA). The aim of the study is to assess the minimal important difference (MID) of the TRIM-AGHD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survey | – | Other: No treatment given |
Who may qualify
- Ages
- 23 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a diagnosis of growth hormone deficiency (GHD), naïve to treatment currently and for at least 6 months prior, who are beginning a new prescription treatment for their GHD. Patients will be selected by sites as per inclusion and exclusion criteria
Key inclusion criteria (6 listed)
- Able to speak read and write English
- GHD (Growth Hormone Deficiency) treatment naïve which is defined as not being on a prescription treatment for their GHD currently and for at least 6 months
- Beginning a new prescription GHD treatment and expected to be on this treatment for GHD for a minimum of 6 months
- GHD of either one of the following criteria: a) Adult onset: subjects who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or traumatic brain injury (TBI), b) Childhood Onset: Subjects who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes
- Confirmed diagnosis of growth hormone deficiency (if a subject satisfies any one of the three following criteria): a) For the insulin tolerance test (ITT) or glucagon test both performed within the last five years: the validated cut-off for GHD in adults is a peak GH response of below 3.0 ng/mL (3 microg/L), b) For growth hormone releasing hormone (GHRH) +Arginine test performed within the last five years: for those subjects with a body mass index (BMI) below 25 kg/m^2, a peak GH below 11 ng/mL (microg /L); for BMI 25-30 kg/m^2, a peak GH below 8 ng/mL (8 microg/L); for BMI above 30 kg/m^2, a peak GH below 4 ng/mL 341 (4 microg/L ), c) Three or more pituitary hormone deficiencies at screening
Key exclusion criteria (8 listed)
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Patients who have been on a prescription medication for treatment of GHD in past 6 months
- Patients with a total Beck Depression Inventory II (BDI-II) score greater than 25
- Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
- Acute severe illness associated with weight loss in the last 6 months (defined as a loss of more than 5.0% total body weight)
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 |
|---|---|---|
| No treatment givenSubject will only fill out a questionnaire when entering the non-interventional study | Other | Survey |
Primary outcome
Changes in CGI (Clinician Global Impression Scale)
Time frame: After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment
Changes in PGI (Patient Global Impression Scale)
Time frame: After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment
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 Jan 2017.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 1 site in United States.
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 6 inclusion and 8 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 Jan 2017. 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 United States. 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.
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?
Changes in CGI (Clinician Global Impression Scale) (time frame: After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2017.