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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004388-34 | EudraCT Number |
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Terminated due to lack of eligible patients
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This trial will investigate the relationship of sleep, daytime performance and nocturia in patients treated with Desmopressin or placebo. Male and Female patients will be administered Desmopressin or Placebo every day for 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental A | Experimental |
| |
| Experimental B | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desmopressin | Drug |
| ||
| Placebo (not active) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of nocturnal voids | As measured by voiding diary | 1 month and 3 months |
| Wake after sleep onset | i.e. time in minutes of epochs scored as wake from sleep onset latency until lights on. Measured by Polysomnography | 1 month and 3 months |
| Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale | Daytime performance | 1 month and 3 months |
| Mean time to first void | As measured by voiding diary | 1 month and 3 months |
| Sleep efficiency | Sleep efficiency equals total sleep time divided by total recording time multiplied by 100. Measured by Polysomnography | 1 month and 3 months |
| Sleep stage N1, N2, N3, (sleep stages in NREM (non-rapid eye movement) and REM (rapid eye movement) as a percentage of total sleep time | Measured by Polysomnography | 1 month and 3 months |
| Number of awakenings due to nocturia | Measured by Polysomnography | 1 month and 3 months |
| Latency to slow-wave sleep | Measured by Polysomnography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surrey Clinical Research Centre | Surrey | United Kingdom |
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| 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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| ID | Term |
|---|---|
| D003894 | Deamino Arginine Vasopressin |
| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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| Drug |
|
| 1 month and 3 months |
| Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset | Measured by Actigraphy | 1 month and 3 months |
| Percent of sleep | Measured by Actigraphy | 1 month and 3 months |
| Number of awakenings due to nocturia | Measured by Actigraphy | 1 month and 3 months |
| Quality of life score measured by EQ-5D-5L | Daytime performance | 1 month and 3 months |
| Safety - incidence of adverse events | 1 month and 3 months |
| Safety - clinically significant changes in lab values | 1 week and 3 months |
| Safety - clinically significant changes in vital signs | 1 week, 1 month and 3 months |
| Safety - clinically significant changes in physical examination | 3 months |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |