Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD
NCT ID: NCT03831880
Last Updated: 2021-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
87 participants
INTERVENTIONAL
2019-02-07
2020-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Daily to Weekly
Genotropin to somatrogon
Genotropin
Genotropin (dose \[mg\] at time of enrollment) given subcutaneously once daily
somatrogon
0.66 mg/kg/week given subcutaneously once weekly
Weekly to Daily
somatrogon to Genotropin
Genotropin
Genotropin (dose \[mg\] at time of enrollment) given subcutaneously once daily
somatrogon
0.66 mg/kg/week given subcutaneously once weekly
Interventions
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Genotropin
Genotropin (dose \[mg\] at time of enrollment) given subcutaneously once daily
somatrogon
0.66 mg/kg/week given subcutaneously once weekly
Eligibility Criteria
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Inclusion Criteria
2. Currently on treatment with either Genotropin Pen®, Genotropin GoQuick Pen®, HumatroPen® (United States of America \[USA\] only), or Omnitrope® Pen (USA only) ≥3 months and have been compliant on a stable dose (±10%) for at least 3 months prior to screening.
3. IGF I SDS \< 2.
4. Subjects on hormonal replacement therapy for other hypothalamic pituitary axis (HPA) hormonal deficiencies and/or diabetes insipidus must be on an optimized and stable treatment regimen, as determined by the Investigator, for at least 3 months prior to screening.
Exclusion Criteria
2. History of radiation therapy or chemotherapy.
3. Children with psychosocial dwarfism.
4. Children born small for gestational age (SGA) - birth weight and/or birth length \< 2 SDS for gestational age.
5. Other causes of short stature such as uncontrolled primary hypothyroidism and rickets.
6. Chromosomal abnormalities including Turner's syndrome, Laron syndrome, Noonan syndrome, Prader Willi syndrome, Russell Silver syndrome, short stature homeobox (SHOX) mutations/deletions or skeletal dysplasias.
7. Treatment with regularly scheduled daily or weekly injectable medications other than Genotropin® Pen, Genotropin GoQuick®, HumatroPen® (USA only), or Omnitrope® Pen (USA only).
8. Diabetes Mellitus.
9. Current treatment with Genotropin MiniQuick.
10. History of any exposure to a long acting hGH preparation.
11. Known or suspected human immunodeficiency virus (HIV) positive patient, or patient with advanced diseases such as acquired immunodeficiency syndrome (AIDS) or tuberculosis.
12. Drug, substance, or alcohol abuse.
13. Known hypersensitivity to the components of the medication.
14. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
15. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
16. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
17. Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation.
18. Patient and/or the parent/legal guardian are likely to be non-compliant with respect to study conduct.
19. Subject and/or the parent/legal guardian are unable to understand written and/or verbal instructions on the proper use of growth hormone injection devices.
20. Children with closed epiphyses (this determination can be based on available existing clinical data).
3 Years
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Center of Excellence in Diabetes and Endocrinology
Sacramento, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Rocky Mountain Pediatric Endocrinology
Centennial, Colorado, United States
Pediatric Endocrine Associates, PC
Greenwood Village, Colorado, United States
Nemours Children's Health System
Jacksonville, Florida, United States
Nemours Children's Specialty Care
Jacksonville, Florida, United States
Nemours Biomedical Research
Orlando, Florida, United States
Nemours Children's Hospital
Orlando, Florida, United States
Nemours Children's Clinic
Pensacola, Florida, United States
Shriners Hospitals for Children
Tampa, Florida, United States
Emory Children's Center
Atlanta, Georgia, United States
IU Health Pharmacy
Indianapolis, Indiana, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
MultiCare Health System - Mary Bridge Children's Health Center
Tacoma, Washington, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States
First Pediatric Clinic UMHAT "St. Marina" EAD
Varna, , Bulgaria
Fakultni nemocnice Brno, Pediatricka Klinika
Brno, , Czechia
Nemocnicni lekarna FN Brno
Brno, , Czechia
Fakultni nemocnice v Motole, Pediatricka klinika 2.LF UK a FN Motol
Prague, , Czechia
Nemocnicni lekarna FN Motol
Prague, , Czechia
Nemocnicna Lekaren Nudch
Bratislava, , Slovakia
Národný ústav detských chorôb, Detská klinika
Bratislava, , Slovakia
Detská fakultná nemocnica Košice Klinika detí a dorastu LF UPJŠ a DFN
Košice, , Slovakia
Nemocnica lekaren DFN Kosice, Klinika deti a dorastu
Košice, , Slovakia
St. Georges University Hospitals NHS Foundation Trust
London, , United Kingdom
St. Georges University Hospital NHS Foundation Trust
London, , United Kingdom
The Institute of Child Health, University College London
London, , United Kingdom
Great Ormond Street Hospital
London, , United Kingdom
NIHR Clinical Research Facility, Great Ormond Street Hospital for Children NHS Trust
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2018-000918-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C0311002
Identifier Type: -
Identifier Source: org_study_id