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

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ClinicalTrials.gov Identifier: NCT02005198
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date December 3, 2013
First Posted Date December 9, 2013
Last Update Posted Date January 5, 2017
Study Start Date March 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 3, 2013)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02005198 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
Official Title Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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
Condition
  • Growth Hormone Disorder
  • Adult Growth Hormone Deficiency
Intervention Other: No treatment given
Subject will only fill out a questionnaire when entering the non-interventional study
Study Groups/Cohorts Survey
Intervention: Other: No treatment given
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 6, 2016)
98
Original Estimated Enrollment
 (submitted: December 3, 2013)
50
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 23 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02005198
Other Study ID Numbers NN8640-4123
U1111-1146-1750 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2017