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To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.
Nocturia, defined as waking to urinate at least once per night between periods of sleep, is a common complaint which increases with age. VA106483 is a non-peptide drug VA106483 that is being developed for the treatment of nocturia in males.
The purpose of this study is to investigate the effect of VA106483 on the number of times the subject needs to get up to urinate (nocturnal void) per night and to determine the effect on the time between the subject's bedtime and the time they first wake up to urinate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VA106483 1mg | Experimental |
| |
| VA106483 2mg | Experimental |
| |
| VA106483 4mg | Experimental |
| |
| Sugar pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VA106483 | Drug | Drug: VA106483 Once daily oral dose of 1 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 2 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 4 mg VA106483 or matching placebo for 28 days. Placebo: as above |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the mean number of nocturnal voids per night | 70 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean duration of first sleep period | 70 days | |
| Change in nocturia-related quality of life | 70 days | |
| Incidence and frequency of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mira Baron | Rapid Medical Research, Inc. | Principal Investigator |
| David Beccia | Medical & Clinical Research Associates | Principal Investigator |
| Kenneth Blaze | South Broward Research, LLC | Principal Investigator |
| Mitchell Efros | Accumed Research Associates | Principal Investigator |
| Marc Gittelman | South Florida Medical Research | Principal Investigator |
| Evan Goldfischer | Hudson Valley Urology, PC | Principal Investigator |
| Elizabeth Houser | The Urology Team P.A. | Principal Investigator |
| Theodore Johnson II | Emory University | Principal Investigator |
| Steven Kester | Urology Center of Florida | Principal Investigator |
| Richard Lotenfoe |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Research Center, LLC | Birmingham | Alabama | 35209 | United States | ||
| Genova Clinical Research |
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| 70 days |
| Frequency of hyponatraemia | 70 days |
| Change from baseline in safety laboratory parameters | 70 days |
| Discovery Clinical Trials |
| Principal Investigator |
| Earl Martin | Martin Diagnostic Clinic | Principal Investigator |
| H. David Mitcheson | Bay State Clinical Trials, Inc. | Principal Investigator |
| Chris Ng | Tower Urology Medical Group | Principal Investigator |
| Aris Nikas | Health Texas Research Institute | Principal Investigator |
| Joseph Parkhurst | Parkhurst Research Organization | Principal Investigator |
| Bruce Rankin | Avail Clinical Research LLC | Principal Investigator |
| Leah Schmidt | Genova Clinical Research | Principal Investigator |
| Howard Hezmall | Urology Associates of North Texas | Principal Investigator |
| Wilbur Wells Jnr | Alabama Research Center, LLC | Principal Investigator |
| Rafael Wurzel | Grove Hill Clinical Research | Principal Investigator |
| Tucson |
| Arizona |
| 85741 |
| United States |
| Tower Urology Medical Group | Los Angeles | California | 90048 | United States |
| Grove Hill Clinical Research | New Britian | Connecticut | 06052 | United States |
| South Florida Medical Research | Aventura | Florida | 33180 | United States |
| Discovery Clinical Trials | Celebration | Florida | 34747 | United States |
| Avail Clinical Research LLC | DeLand | Florida | 32720 | United States |
| Urology Center of Florida | Hialeah | Florida | 33012 | United States |
| South Broward Research, LLC | Pembroke Pines | Florida | 33027 | United States |
| Bay State Clinical Trials, Inc. | Watertown | Massachusetts | 02472 | United States |
| Medical & Clinical Research Associates | Bay Shore | New York | 11706 | United States |
| Accumed Research Associates | Garden City | New York | 11530 | United States |
| Hudson Valley Urology, PC | Poughkeepsie | New York | 12601 | United States |
| Rapid Medical Research, Inc. | Clevland | Ohio | 44122 | United States |
| Parkhurst Research Organization | Bethany | Oklahoma | 73008 | United States |
| Urology Associates of North Texas | Arlington | Texas | 76017 | United States |
| The Urology Team P.A. | Austin | Texas | 78759 | United States |
| Health Texas Research Institute | San Antonio | Texas | 78212 | United States |
| Martin Diagnostic Clinic | Tomball | Texas | 77375 | United States |
| ID | Term |
|---|---|
| D053158 | Nocturia |
| D007010 | Hyponatremia |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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