Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Gr… (NCT02005198) | Clinical Trial Compass
CompletedNot Applicable
Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
United States98 participantsStarted 2014-03
Plain-language 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.
Who can participate
Age range23 Years – 79 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 …
What they're measuring
1
Changes in CGI (Clinician Global Impression Scale)
Timeframe: After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment
2
Changes in PGI (Patient Global Impression Scale)
Timeframe: After the physician scheduled visits closest to week 8 and week 26 after initiation of treatment