Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1168-7911 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is conducted in Europe and the United States of America (USA). The aim of the study is to validate two measures for growth hormone deficiency in children, the Treatment Related Impact Measure of Childhood Growth Hormone Deficiency (TRIM-CGHD) and the Treatment Burden Measure of Childhood Growth Hormone Deficiency (TB-CGHD).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Child Treatment Naïve group (Group A) | Pre-pubertal boy or girl, ages of 9 to 13 years with a confirmed diagnosis of GHD prior to enrolment as determined by one GH stimulation test, defined as a peak GH level of equal or below 7.0 ng/ml. |
| |
| Child Maintenance group (Group B) | Pre-pubertal boy or girl, ages of 9 to 13 years with a confirmed diagnosis of GHD prior to enrolment as determined by one GH stimulation test, defined as a peak GH level of equal or below 10.0 ng/ml who have been taking prescription treatment for GHD for 6 months or more. |
| |
| Parent Treatment Naïve group (Group C) | Parents/guardians, who live with a pre-pubertal boy or girl, age 4 to 9 years with a confirmed diagnosis of GHD prior to enrolment as determined by one GH stimulation test, defined as a peak GH level of below or equal to 7.0 ng/ml. |
| |
| Parent Maintenance group (Group D) | Parents/guardians, who live with a pre-pubertal boy or girl, age 4 to 9 years with a confirmed diagnosis of GHD prior to enrolment as determined by one GH stimulation test, defined as a peak GH level of below or equal to 10.0 ng/ml who have been taking prescription treatment for GHD for 6 months or more. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | No treatment given. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in CGI (Clinician Global Impression Scale) | After the physician scheduled MCID assessment visit (variable between week 3 and week 11) and week 12 follow-up visit after initiation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in PGI (Patient Global Impression Scale) | After the physician scheduled MCID assessment visit (variable between week 3 and week 11) and week 12 follow-up visit after initiation of treatment |
Not provided
Inclusion Criteria:
Not provided
Not provided
The 2 populations (child and parent/guardian) will each be divided into a Treatment Naïve group and a Maintenance group.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Phoenix | Arizona | 85054 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36255609 | Derived | Brod M, Rasmussen MH, Alolga S, Beck JF, Bushnell DM, Lee KW, Maniatis A. Psychometric Validation of the Growth Hormone Deficiency-Child Treatment Burden Measure (GHD-CTB) and the Growth Hormone Deficiency-Parent Treatment Burden Measure (GHD-PTB). Pharmacoecon Open. 2023 Jan;7(1):121-138. doi: 10.1007/s41669-022-00373-z. Epub 2022 Oct 18. | |
| 33433896 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| Centennial |
| Colorado |
| 80112 |
| United States |
| Novo Nordisk Investigational Site | Wilmington | Delaware | 19803 | United States |
| Novo Nordisk Investigational Site | Margate | Florida | 33063 | United States |
| Novo Nordisk Investigational Site | Miami | Florida | 33155 | United States |
| Novo Nordisk Investigational Site | Tallahassee | Florida | 32308 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30342-1551 | United States |
| Novo Nordisk Investigational Site | Wheaton | Illinois | 60187 | United States |
| Novo Nordisk Investigational Site | Iowa City | Iowa | 52242 | United States |
| Novo Nordisk Investigational Site | Louisville | Kentucky | 40202 | United States |
| Novo Nordisk Investigational Site | Boston | Massachusetts | 02114 | United States |
| Novo Nordisk Investigational Site | Saint Paul | Minnesota | 55102 | United States |
| Novo Nordisk Investigational Site | St Louis | Missouri | 63017 | United States |
| Novo Nordisk Investigational Site | Lebanon | New Hampshire | 03756-1000 | United States |
| Novo Nordisk Investigational Site | Albany | New York | 12208-3412 | United States |
| Novo Nordisk Investigational Site | Buffalo | New York | 14203 | United States |
| Novo Nordisk Investigational Site | Mineola | New York | 11501 | United States |
| Novo Nordisk Investigational Site | New York | New York | 10029 | United States |
| Novo Nordisk Investigational Site | Spring Valley | New York | 10977 | United States |
| Novo Nordisk Investigational Site | Cleveland | Ohio | 44195 | United States |
| Novo Nordisk Investigational Site | Columbus | Ohio | 43235 | United States |
| Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | 15218 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75230 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75235 | United States |
| Novo Nordisk Investigational Site | Birmingham | B4 6NH | United Kingdom |
| Novo Nordisk Investigational Site | Liverpool | L12 2AP | United Kingdom |
| Novo Nordisk Investigational Site | London | WC1N 3JH | United Kingdom |
| Novo Nordisk Investigational Site | Manchester | M13 9WL | United Kingdom |
| Brod M, Hojby Rasmussen M, Vad K, Alolga S, Bushnell DM, Bedoin J, Maniatis A. Psychometric Validation of the Growth Hormone Deficiency-Child Impact Measure (GHD-CIM). Pharmacoecon Open. 2021 Sep;5(3):505-518. doi: 10.1007/s41669-020-00252-5. Epub 2021 Jan 12. |
| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided