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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A. Desmopressin 10 microgram | Active Comparator |
| |
| B. Desmopressin 25 microgram | Active Comparator |
| |
| C. Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A. Desmopressin 10 microgram | Drug | 1 orally disintegrating tablet every night during study period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean number of nocturnal voids | During 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean time to first void | During 12 weeks | |
| Responder status (33% reduction in nocturnal voids) | During 12 weeks | |
| Change from baseline in mean number of nocturnal voids |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferríng Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japanese Red Cross Nagoya Daiichi Hospital | Aichi | Japan | ||||
| Clinic Tsudanuma |
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| B: Desmopressin 25 microgram | Drug | 1 orally disintegrating tablet every night during study period |
|
| C: Placebo | Drug | 1 orally disintegrating tablet every night during study period |
|
| 1, 4, 8 and 12 weeks |
| Change from baseline in mean time to first void | 1, 4, 8 and 12 weeks |
| Responder status (33% reduction in nocturnal voids) | 1, 4, 8 and 12 weeks |
| Change from baseline in mean nocturnal urine volume | 1, 4, 8 and 12 weeks |
| Change from baseline in nocturnal polyuria index | 1, 4, 8 and 12 weeks |
| Change from baseline in the effect on sleep disturbance | 1, 4, 8 and 12 weeks |
| Change from baseline in the impact on quality of life | 12 weeks |
| Adverse events, changes from baseline in serum sodium level, laboratory values | During 12 weeks |
| 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 |
| Izumino Hospital, Bouchikai | Kochi | Japan |
| Kamei Clinic | Kochi | Japan |
| Den Urology Clinic | Osaka | Japan |
| Iwasa Clinic | Osaka | Japan |
| Kanno Clinic | Osaka | Japan |
| Morimoto Clinic | Osaka | Japan |
| Naka Clinic | Osaka | Japan |
| Uemura Clinic | Osaka | Japan |
| Urology department Kuroda Clinic | Osaka | Japan |
| Yamaguchi Clinic | Osaka | Japan |
| Yamanaka Clinic | Osaka | Japan |
| Fukuda Clinic | Saitama | Japan |
| Yasuda Urology Clinic | Saitama | Japan |
| Hirano Clinic | Tokyo | Japan |
| Hirata Internal Medicine Urology Clinic | Tokyo | Japan |
| J Tower Clinic | Tokyo | Japan |
| Koganeibashi Sakura Clinic | Tokyo | Japan |
| Kunitachi Sakura Hospital | Tokyo | Japan |
| Kusunoki Clinic | Tokyo | Japan |
| Moriguchi Clinic | Tokyo | Japan |
| Nakanoma Clinic Urology Department | Tokyo | Japan |
| Ogawa Clinic | Tokyo | Japan |
| Ogikubo Ekimae Clinic | Tokyo | Japan |
| Shibuya Shin-minamiguchi Clinic | Tokyo | Japan |
| Tokyo Kamata Hospital | Tokyo | Japan |
| Toru Clinic | Tokyo | Japan |
| ID | Term |
|---|---|
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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