Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209261
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-09-13
Brief Title:
A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis PNE
Sponsor:
Ferring Pharmaceuticals
Organization:
Ferring Pharmaceuticals
Study Overview
Official Title:
A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin Oral Lyophilisate 120 μg and 240 μg and 2 Different Daily Doses of Minirin Tablet 02 mg and 2 x 02 mg in Children and Adolescents With Primary Nocturnal Enuresis PNE
Status:
COMPLETED
Status Verified Date:
2011-05
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:
PALAT
Brief Summary:
To evaluate the preference of subjects for Minirin oral lyophilisate treatment compared with Minirin tablet treatment after 6 weeks
To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data
To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale To validate a PNE Quality of Life QoL questionnaire To evaluate safety To compare compliance with the 2 formulations
To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data
To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale To validate a PNE Quality of Life QoL questionnaire To evaluate safety To compare compliance with the 2 formulations
Detailed Description:
To evaluate the preference of subjects for Minirin oral lyophilisate treatment compared with Minirin tablet treatment after 6 weeks
To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data
To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale To validate a PNE Quality of Life QoL questionnaire To evaluate safety To compare compliance with the 2 formulations
To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data
To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale To validate a PNE Quality of Life QoL questionnaire To evaluate safety To compare compliance with the 2 formulations
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