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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 August 2023 |
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Main ID: |
NCT03718234 |
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Date of registration:
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11/10/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia
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Scientific title:
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Interval Bolus Delivery of Subcutaneous Hydrocortisone Via Infusion Pump in Children With Congenital Adrenal Hyperplasia |
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Date of first enrolment:
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January 1, 2019 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03718234 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Kyriaki Sarafoglou, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Minnesota |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children 4 - 18 years of age.
- Classic congenital adrenal hyperplasia (CAH) as confirmed by hormonal and molecular
testing.
- Patients who have been on the same HC dosing regimen for 1 month
Exclusion Criteria:
- Patients with non-classic CAH.
- Patients on:
- Dexamethasone
- Prednisone, or
- inhaled steroids.
- Patients with body surface areas under 1m2 or over 2m2
- Non-English speaking patients
Age minimum:
4 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Adrenal Gland Disease
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Adrenal Hyperplasia
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Congenital Adrenal Hyperplasia
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Genetic Diseases, Inborn
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Adrenocortical Hyperfunction
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Hydrocortisone
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Congenital Disorders
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Disorders of Sex Development
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Steroid Metabolic Diseases, Inborn
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Urogenital Abnormalities
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Hyperplasia
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Intervention(s)
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Drug: Subcutaneous hydrocortisone
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Drug: Standard glucocorticoid therapy
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Primary Outcome(s)
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Serum concentrations will be within an acceptable range
[Time Frame: From date of randomization assessed up to 20 weeks.]
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Duration of hypocortisolemia and hypercortisolemia will be significantly shorter
[Time Frame: From date of randomization assessed up to 20 weeks.]
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Secondary ID(s)
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FD-R-6100
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PEDS-2018-26475
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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