Clinical Trial: Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis

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

Official Title: A Double-blind, Placebo-controlled, Phase III Comparative Study With FE992026 in Children and Adolescents With Reduced Night-time Urinary Osmolarity-type Nocturnal Enuresis

Brief Summary: This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary osmolality."

Detailed Summary:
Sponsor: Ferring Pharmaceuticals

Current Primary Outcome: Change in the Number of Wet Nights Between Baseline and Treatment Period II [ Time Frame: Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation). ]

The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period II.


Original Primary Outcome: Number of wet nights [ Time Frame: Between the baseline and a 14-day period on the third and fourth weeks (period II) after treatment initiation ]

Current Secondary Outcome:

  • Change in Number of Wet Nights Between Baseline and Treatment Period I [ Time Frame: Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation). ]
    The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period I.
  • Change in Number of Wet Nights Between Treatment Periods I and II [ Time Frame: Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4) ]
    The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Treatment Period I minus the number of wet nights during the 14-day Treatment Period II.


Original Secondary Outcome:

  • Number of wet nights [ Time Frame: Between baseline and a 14-day period on the first and second weeks (period I) after treatment initiation ]
  • Number of wet nights [ Time Frame: Between treatment periods I and II ]
    Between treament period I (1st and 2nd weeks) and period II (3rd and 4th weeks)


Information By: Ferring Pharmaceuticals

Dates:
Date Received: March 1, 2010
Date Started: January 2010
Date Completion:
Last Updated: September 27, 2011
Last Verified: September 2011