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) (PALAT)

NCT00209261 Phase 4 COMPLETED

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

Details

Lead sponsor	Ferring Pharmaceuticals
Phase	Phase 4
Status	COMPLETED
Enrolment	221
Start date	2004-12
Completion	2005-09

Conditions

• Primary Nocturnal Enuresis

Interventions

• MINIRIN Oral Lyophilisate
• Minirin tablet

Primary outcomes

• The primary endpoint will be the difference in the proportion of subjects who preferred each formulation at the end of the 6-week treatment period. — 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks.

Countries

France