Trial Outcomes & Findings for Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus (NCT NCT00478335)
NCT ID: NCT00478335
Last Updated: 2018-02-12
Results Overview
urine volume in mL/d
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
4-days
Results posted on
2018-02-12
Participant Flow
Participant milestones
| Measure |
Experimental First Then Standard
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).
|
Standard First Then Experimental
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 1 (4 Days)
STARTED
|
2
|
2
|
|
Period 1 (4 Days)
COMPLETED
|
2
|
2
|
|
Period 1 (4 Days)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (4 Days)
STARTED
|
2
|
2
|
|
Period 2 (4 Days)
COMPLETED
|
2
|
2
|
|
Period 2 (4 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus
Baseline characteristics by cohort
| Measure |
Experimental First Then Standard
n=2 Participants
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).
|
Standard First Then Experimental
n=2 Participants
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
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-daysurine volume in mL/d
Outcome measures
| Measure |
Experimental First Then Standard
n=2 Participants
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
|
Standard First Then Experimental
n=2 Participants
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).
|
|---|---|---|
|
24h Urine Volume
Period 1
|
6475 urine volume in mL/d
Standard Deviation 742
|
4178 urine volume in mL/d
Standard Deviation 590
|
|
24h Urine Volume
Period 2
|
6652 urine volume in mL/d
Standard Deviation 1305
|
4188 urine volume in mL/d
Standard Deviation 1679
|
Adverse Events
Experimental First Then Standard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard First Then Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Melissa Cadnapaphornchai, MD
University of Colorado Denver
Phone: 720776263
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place