The purpose of the study is to investigate the efficacy and safety of two different dose levels of desmopressin orally disintegrating tablets against placebo for the treatment of nocturia in adult women during 12 weeks treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
178
1 orally disintegrating tablet every night during study period
1 orally disintegrating tablet every night during study period
1 orally disintegrating tablet every night during study period
Japanese Red Cross Nagoya Daiichi Hospital
Change from baseline in mean number of nocturnal voids
Time frame: During 12 weeks
Change from baseline in mean time to first void
Time frame: During 12 weeks
Responder status (33% reduction in nocturnal voids)
Time frame: During 12 weeks
Change from baseline in mean number of nocturnal voids
Time frame: 1, 4, 8 and 12 weeks
Change from baseline in mean time to first void
Time frame: 1, 4, 8 and 12 weeks
Responder status (33% reduction in nocturnal voids)
Time frame: 1, 4, 8 and 12 weeks
Change from baseline in mean nocturnal urine volume
Time frame: 1, 4, 8 and 12 weeks
Change from baseline in nocturnal polyuria index
Time frame: 1, 4, 8 and 12 weeks
Change from baseline in the effect on sleep disturbance
Time frame: 1, 4, 8 and 12 weeks
Change from baseline in the impact on quality of life
Time frame: 12 weeks
Adverse events, changes from baseline in serum sodium level, laboratory values
Time frame: During 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Aichi, Japan
Clinic Tsudanuma
Chiba, Japan
University of Fukui Hospital
Fukui, Japan
Kato Clinic
Gunma, Japan
Umeyama Clinic
Gunma, Japan
Harada Urology Clinic
Hyōgo, Japan
Sakaguchi Urological Clinic
Hyōgo, Japan
Nakamura Urology Clinic
Kanagawa, Japan
Nishi-Yokohama International Hospital
Kanagawa, Japan
Yokohama Shinmidori General Hospital
Kanagawa, Japan
...and 26 more locations