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Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus

This study has been completed.
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00478335
First received: May 23, 2007
Last updated: December 19, 2012
Last verified: October 2008
History of Changes
  Purpose

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).


Condition Intervention
Nephrogenic Diabetes Insipidus
 Drug: sildenafil
Drug: calcitonin
Drug: hydrochlorothiazide/amiloride
Drug: indomethacin
Drug: Placebo for sildenafil
Drug: placebo for calcitonin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Urine volume [ Time Frame: 24-hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of urination [ Time Frame: 24-hour ] [ Designated as safety issue: No ]
  • Urine osmolality [ Time Frame: 24-hour ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: May 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
4-day treatment with hydrochlorothiazide/amiloride, indomethacin, calcitonin, sildenafil
 Drug: sildenafil
25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight
Other Name: Viagra
Drug: calcitonin
one nasal spray daily for 4 days
Other Name: Miacalcic
Drug: hydrochlorothiazide/amiloride
25 mg/2.5 mg BID or 50 mg/5 mg BID x 8 days depending on subject weight
Other Name: Moduret, Moduretic
Drug: indomethacin
50 mg QD or 50 mg BID x 8 days depending on subject weight
Other Name: Indocin
Placebo Comparator: 2
4-day treatment with hydrochlorothiazide/amiloride, indomethacin, placebo for calcitonin, placebo for sildenafil
 Drug: hydrochlorothiazide/amiloride
25 mg/2.5 mg BID or 50 mg/5 mg BID x 8 days depending on subject weight
Other Name: Moduret, Moduretic
Drug: indomethacin
50 mg QD or 50 mg BID x 8 days depending on subject weight
Other Name: Indocin
Drug: Placebo for sildenafil
one tablet daily for 4 days
Drug: placebo for calcitonin
one nasal spray daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 25 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478335

Locations
United States, Colorado
University of Colorado at Denver and Health Sciences Center
Aurora, Colorado, United States, 80045
Denmark
University of Aarhus
Aarhus, Denmark
Sponsors and Collaborators
University of Colorado, Denver
University of Aarhus
Investigators
Principal Investigator: Melissa A Cadnapaphornchai, MD University of Colorado, Denver
  More Information

Additional Information:
Nephrogenic Diabetes Insipidus Foundation  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00478335     History of Changes
Other Study ID Numbers: 06-0588
Study First Received: May 23, 2007
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration
Denmark: Danish Medicines Agency

Keywords provided by University of Colorado, Denver:
congenital nephrogenic diabetes insipidus
polyuria
urine osmolality
aquaporin-2
vasopressin V2 receptor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Insipidus
Diabetes Insipidus, Neurogenic
Diabetes Insipidus, Nephrogenic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Amiloride
Hydrochlorothiazide
Calcitonin Gene-Related Peptide
Arginine Vasopressin
Indomethacin
 Sildenafil
Salmon calcitonin
Calcitonin
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents
Hemostatics

ClinicalTrials.gov processed this record on May 21, 2013