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."
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
89
Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime.
Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.
Akita University Hospital
Akita, Akita, Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima, Hiroshima, Japan
Showa Hospital
Amagasaki, Hyōgo, Japan
Change in the Number of Wet Nights Between Baseline and Treatment Period II
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.
Time frame: Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).
Change in Number of Wet Nights Between Baseline and Treatment Period I
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.
Time frame: Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).
Change in Number of Wet Nights Between Treatment Periods I and II
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.
Time frame: Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)
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Shinko-Kakogawa Hospital
Kakogawa, Hyōgo, Japan
Tamura Children's Clinic
Mito, Ibaraki, Japan
Shinbo Child Clinic
Yokohama, Kanagawa, Japan
Aikawa Station Clinic
Niigata, Niigata, Japan
Kansai Medical University Hirakata Hospital
Hirakata, Osaka, Japan
Kitano Hospital
Osaka, Osaka, Japan
Saitama Childrens Medical Centre
Saitama, Saitama, Japan
...and 5 more locations