NCT00209261

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)

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 (0.2 mg and 2 x 0.2 mg) in Children and Adolescents With Primary Nocturnal Enuresis (PNE)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 5 Years – 15 Years
• Healthy volunteers: Accepted

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

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

Conditions

• Primary Nocturnal Enuresis

Interventions

Type	Name	Description
DRUG	MINIRIN Oral Lyophilisate
DRUG	Minirin tablet

Timeline

• Start date: 2004-12-01
• Primary completion: 2005-08-01
• Completion: 2005-09-01
• First posted: 2005-09-21
• Last updated: 2011-05-19

Locations

1 site across 1 country: France