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Trial record 48 of 231 for:    CALCITONIN SALMON

Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus

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
Recruitment Status : Completed
First Posted : May 24, 2007
Results First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Nephrogenic Diabetes Insipidus
Interventions Drug: sildenafil
Drug: calcitonin
Drug: hydrochlorothiazide/amiloride
Drug: indomethacin
Drug: Placebo for sildenafil
Drug: placebo for calcitonin
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental First Then Standard Standard First Then Experimental
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Experimental phase: 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).

Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).

4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).

Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).

Period Title: Period 1 (4 Days)
Started 2 2
Completed 2 2
Not Completed 0 0
Period Title: Period 2 (4 Days)
Started 2 2
Completed 2 2
Not Completed 0 0
Arm/Group Title Experimental First Then Standard Standard First Then Experimental Total
Hide Arm/Group Description

4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).

Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).

4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).

Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).

Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
crossover
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
<=18 years
2
 100.0%
1
  50.0%
3
  75.0%
Between 18 and 65 years
0
   0.0%
1
  50.0%
1
  25.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
2
 100.0%
2
 100.0%
4
 100.0%
1.Primary Outcome
Title 24h Urine Volume
Hide Description urine volume in mL/d
Time Frame 4-days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental First Then Standard Standard First Then Experimental
Hide Arm/Group Description:

4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).

Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).

on subject weight

4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).

Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).

Overall Number of Participants Analyzed 2 2
Mean (Standard Deviation)
Unit of Measure: urine volume in mL/d
Period 1 6475  (742) 4178  (590)
Period 2 6652  (1305) 4188  (1679)
Time Frame Up to 2 weeks
Adverse Event Reporting Description Adverse events were evaluated based on clinical course and via use of systematic written survey to all participants
 
Arm/Group Title Experimental First Then Standard Standard First Then Experimental
Hide Arm/Group Description

4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).

Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).

4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), Placebo for calcitonin (one nasal spray daily), Placebo for sildenafil (1 tablet daily).

Followed by 4-day treatment with hydrochlorothiazide/amiloride (25 mg/2.5 mg BID or 50 mg/5 mg BID based on subject weight), indomethacin (50 mg QD or 50 mg BID based on subject weight), calcitonin (one nasal spray daily for 4 days), sildenafil (25 mg quaque die (QD) or 50 mg QD x 4 days based on subject weight).

All-Cause Mortality
Experimental First Then Standard Standard First Then Experimental
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Experimental First Then Standard Standard First Then Experimental
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental First Then Standard Standard First Then Experimental
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Melissa Cadnapaphornchai, MD
Organization: University of Colorado Denver
Phone: 720776263
EMail: melissa.cadnapaphornchai@ucdenver.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00478335     History of Changes
Other Study ID Numbers: 06-0588
First Submitted: May 23, 2007
First Posted: May 24, 2007
Results First Submitted: May 27, 2014
Results First Posted: February 12, 2018
Last Update Posted: February 12, 2018