N/A
N=4
Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus
Nephrogenic Diabetes Insipidus
Bottom Line
View on ClinicalTrials.gov: NCT00478335 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: 24h Urine Volume — 6475; 4178; 6652; 4188 urine volume in mL/d
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- sildenafil (Drug); calcitonin (Drug); hydrochlorothiazide/amiloride (Drug); indomethacin (Drug); Placebo for sildenafil (Drug); placebo for calcitonin (Drug)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- Male
- Sponsor
- University of Colorado, Denver
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24h Urine Volume |
6475; 4178; 6652; 4188 | — |
Summary
The purpose of this research study is to determine if two investigational medications will be more effective in decreasing urine output than the currently available and routinely used medications in patients with congenital nephrogenic diabetes insipidus (NDI).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00478335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.