Clinical Trial: 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)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 (0.2 mg and 2 x 0

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


Detailed 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


Sponsor: Ferring Pharmaceuticals

Current Primary Outcome: 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. [ Time Frame: 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks. ]

Original Primary Outcome:

  • The subjects will be asked a question regarding which treatment (Minirin® oral lyophilisate or Minirin® tablet) they preferred at the end of 6 weeks treatment.
  • 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.


Current Secondary Outcome:

  • Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations. [ Time Frame: 3 weeks ]
  • The subjects will be asked to rate the ease of use of each formulation using a 100 mm Visual Analogue Scale (VAS), with 0 = I find it very easy to use this medicine and 100 = I find it very difficult to use this medicine. [ Time Frame: 3 weeks ]
  • Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3. [ Time Frame: 3 weeks ]
  • Safety comparison between the 2 formulations. [ Time Frame: 6 weeks ]
  • Comparison of compliance between the 2 formulations. [ Time Frame: 6 weeks ]
  • The subjects will be asked a question regarding which treatment (Minirin® oral lyophilisate or Minirin® tablet) they preferred at the end of 6 weeks treatment. [ Time Frame: 6 weeks (melt) and 6 weeks (tablet). Total 12 weeks. ]


Original Secondary Outcome:

  • Efficacy will be measured as the difference in the incidence of bedwetting episodes during each 3-week treatment period, compared between formulations.
  • The subjects will be asked to rate the ease of use of each formulation using a 100 mm Visual Analogue Scale (VAS), with 0 = I find it very easy to use this medicine and 100 = I find it very difficult to use this medicine.
  • Subjects will be asked to complete a QoL questionnaire at visit 2 and visit 3.
  • Safety comparison between the 2 formulations.
  • Comparison of compliance between the 2 formulations.


Information By: Ferring Pharmaceuticals

Dates:
Date Received: September 13, 2005
Date Started: December 2004
Date Completion:
Last Updated: May 18, 2011
Last Verified: May 2011