Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226122
Status:
COMPLETED
Last Update Posted:
2010-06-25
First Post:
2005-09-23
Brief Title:
The Effect of Indomethacin in Monosymptomatic Enuresis Nocturnal
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
The Effect of Indomethacin in Monosymptomatic Enuresis Nocturnal
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Monosymptomatic nocturnal enuresis defined as the involuntary loss of urine during the night at an age where voluntary bladder control should have been attained and on the background of normal urinary tract function is a rather common disease of childhood with an estimated prevalence of 5-10 at tha age of 7 and a spontaneous remission rate of 15 per year
The present study consists of two phases an in-patient phase and an ambulatory phase
In the in-patient phase we will examine the regulation of sodium and the circadian rhythm of the hormones that affect this regulation in children with enuresis nocturnal and healthy children as well as the impact of indomethacin on renal water and electrolyte excretion
In the ambulatory phase we will examine the efficacy and safety of a treatment modality consisting of a combination of dDAVP and indomethacin in patients with severe enuresis where dDAVP as monotherapy is inadequate
A significant number of children with enuresis and nocturnal polyuria do not respond to treatment with dDAVP If a combination treatment with dDAVP and indomethacin proves superior to dDAVP alone the regimen could readily be used in those difficult to cure cases of enuresis
The present study consists of two phases an in-patient phase and an ambulatory phase
In the in-patient phase we will examine the regulation of sodium and the circadian rhythm of the hormones that affect this regulation in children with enuresis nocturnal and healthy children as well as the impact of indomethacin on renal water and electrolyte excretion
In the ambulatory phase we will examine the efficacy and safety of a treatment modality consisting of a combination of dDAVP and indomethacin in patients with severe enuresis where dDAVP as monotherapy is inadequate
A significant number of children with enuresis and nocturnal polyuria do not respond to treatment with dDAVP If a combination treatment with dDAVP and indomethacin proves superior to dDAVP alone the regimen could readily be used in those difficult to cure cases of enuresis
Detailed Description:
The in-patient phase is a comparative circadian study of three groups of participants and a non-placebo controlled study of the renal effects of indomethacin with special reference the renal handling of sodium
The ambulatory phase is designed as a randomized double blind crossover placebo controlled for indomethacin study of the efficacy and safety of a combination treatment with indomethacin and dDAVP
In-patient phase Primary effect parameters will be the diuresis urinary osmolality sodium excretion prior to and after the administration of indomethacin
Secondary effect parameters will be the following GFR K excretion creatinine excretion urea excretion as well as urinary concentrations of aquaporin 2 AQP2 PGE2 AVP URO Na-transporter protein concentration of renin ANG II ALDO ANP in plasma prior to and after the administration of indomethacin
Ambulatory phase Primary effect parameter will be the number of dry nights achieved in the two treatment periods Secondary effect parameters will be the nocturnal urine production and the enuresis volumes In-patient phase Day-night ratios will be calculated for all parameters tested The circadian rhythm of hormones blood pressure and electrolyte excretion will be analyzed using COSINOR analysis
The effect of indomethacin on the parameters tested will be compared to the basal measurements using students t-test ANOVA for repeated measurements or non-parametric tests All statistical inference will take place on a protocol population basis
Ambulatory phase The efficacy of the combination treatment will be tested against placebo only for indomethacin with help of students t-test x2 test or non-parametric tests
The results from the home recordings will be compared for the two treatment periods using non-parametric tests The effect parameters that will undergo statistical analysis are the number of wet nights the enuresis volume and the nocturnal urine production The analysis will be on the basis of intention to treat population
The ambulatory phase is designed as a randomized double blind crossover placebo controlled for indomethacin study of the efficacy and safety of a combination treatment with indomethacin and dDAVP
In-patient phase Primary effect parameters will be the diuresis urinary osmolality sodium excretion prior to and after the administration of indomethacin
Secondary effect parameters will be the following GFR K excretion creatinine excretion urea excretion as well as urinary concentrations of aquaporin 2 AQP2 PGE2 AVP URO Na-transporter protein concentration of renin ANG II ALDO ANP in plasma prior to and after the administration of indomethacin
Ambulatory phase Primary effect parameter will be the number of dry nights achieved in the two treatment periods Secondary effect parameters will be the nocturnal urine production and the enuresis volumes In-patient phase Day-night ratios will be calculated for all parameters tested The circadian rhythm of hormones blood pressure and electrolyte excretion will be analyzed using COSINOR analysis
The effect of indomethacin on the parameters tested will be compared to the basal measurements using students t-test ANOVA for repeated measurements or non-parametric tests All statistical inference will take place on a protocol population basis
Ambulatory phase The efficacy of the combination treatment will be tested against placebo only for indomethacin with help of students t-test x2 test or non-parametric tests
The results from the home recordings will be compared for the two treatment periods using non-parametric tests The effect parameters that will undergo statistical analysis are the number of wet nights the enuresis volume and the nocturnal urine production The analysis will be on the basis of intention to treat population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01 | None | None | None |