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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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12 December 2020 |
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Main ID: |
NCT00478335 |
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Date of registration:
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23/05/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus
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Scientific title:
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Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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4 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00478335 |
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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: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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United States
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Contacts
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Name:
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Melissa A Cadnapaphornchai, 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 Colorado, Denver |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Known diagnosis of Congenital Nephrogenic Diabetes Insipidus (CNDI)
- Age 5 to 25 years
- Normal kidney function
- Post-void residual urine < 200 ml (determined by bladder ultrasound)
Exclusion Criteria:
- Impaired kidney function
- Known urinary retention or bladder dysfunction
- High blood pressure
- Other significant chronic medical disease (e.g., heart failure, liver disease, etc.)
- Allergy to study drugs
Age minimum:
5 Years
Age maximum:
25 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Nephrogenic Diabetes Insipidus
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Intervention(s)
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Drug: indomethacin
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Drug: Placebo for sildenafil
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Drug: hydrochlorothiazide/amiloride
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Drug: placebo for calcitonin
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Drug: calcitonin
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Drug: sildenafil
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Primary Outcome(s)
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24h Urine Volume
[Time Frame: 4-days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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