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Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus

NCT00478335 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-02-12

Study results available
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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).

Conditions

  • Nephrogenic Diabetes Insipidus

Interventions

DRUG

sildenafil

25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight

DRUG

calcitonin

one nasal spray daily for 4 days

DRUG

hydrochlorothiazide/amiloride

25 mg/2.5 mg BID or 50 mg/5 mg BID x 8 days depending on subject weight

DRUG

indomethacin

50 mg QD or 50 mg BID x 8 days depending on subject weight

DRUG

Placebo for sildenafil

one tablet daily for 4 days

DRUG

placebo for calcitonin

one nasal spray daily

Sponsors & Collaborators

  • University of Aarhus

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Melissa A Cadnapaphornchai, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
25 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States
  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00478335 on ClinicalTrials.gov