Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00478335 |
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Recruitment Status :
Completed
First Posted : May 24, 2007
Results First Posted : February 12, 2018
Last Update Posted : February 12, 2018
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Sponsor:
University of Colorado, Denver
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
University of Colorado, Denver
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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 | Phase |
|---|---|---|
| Nephrogenic Diabetes Insipidus | Drug: sildenafil Drug: calcitonin Drug: hydrochlorothiazide/amiloride Drug: indomethacin Drug: Placebo for sildenafil Drug: placebo for calcitonin | Not Applicable |
Show Detailed Description
| 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 |
| Actual Primary Completion Date : | October 2012 |
| Actual Study Completion Date : | October 2012 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Active Therapy
4-day treatment with hydrochlorothiazide/amiloride, indomethacin, calcitonin, sildenafil
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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 |
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Placebo Comparator: Placebo Control
4-day treatment with hydrochlorothiazide/amiloride, indomethacin, placebo for calcitonin, placebo for sildenafil
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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 |
Primary Outcome Measures :
- 24h Urine Volume [ Time Frame: 4-days ]urine volume in mL/d
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
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 |
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 |
| Results First Posted: | February 12, 2018 |
| Last Update Posted: | February 12, 2018 |
| Last Verified: | February 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by University of Colorado, Denver:
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congenital nephrogenic diabetes insipidus polyuria urine osmolality aquaporin-2 vasopressin V2 receptor |
Additional relevant MeSH terms:
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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 |