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Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) | Clinical Trials | Clareo Health

COMPLETED

Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)

NCT02005198•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

23 - 79 years

Sex

ALL

Healthy Volunteers

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 before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)

Exclusion Criteria

•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

Locations (1)

Novo Nordisk Investigational Site

Princeton, New Jersey, United States

Key Dates

Start Date

March 1, 2014

Primary Completion Date

December 1, 2015

Completion Date

December 1, 2015

Last Updated

January 5, 2017

Enrollment

ACTUAL participants

Conditions

Growth Hormone DisorderAdult Growth Hormone Deficiency

Interventions

No treatment given

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)

Inclusion Criteria

Exclusion Criteria

Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®

A Study of GS3-007a for Oral Suspension in the Diagnosis of Adult Growth Hormone Deficiency (AGHD)

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)