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Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus

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ClinicalTrials.gov Identifier: NCT00478335
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : December 21, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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).

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

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus
Study Start Date : May 2007
Primary Completion Date : October 2012
Study Completion Date : October 2012


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Urine volume [ Time Frame: 24-hour ]

Secondary Outcome Measures :
  1. Frequency of urination [ Time Frame: 24-hour ]
  2. Urine osmolality [ Time Frame: 24-hour ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00478335     History of Changes
Other Study ID Numbers: 06-0588
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: October 2008

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, Nephrogenic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Sildenafil Citrate
Calcitonin Gene-Related Peptide
Indomethacin
Hydrochlorothiazide
Amiloride
Arginine Vasopressin
Salmon calcitonin
Calcitonin
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Anti-Inflammatory Agents, Non-Steroidal