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This is a Phase IIa study to evaluate the efficacy, safety and tolerability of GW679769 vs placebo on symptoms of urgency with urge incontinence, frequency and nocturia associated with overactive bladder in women.
A Twelve-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Forced Titration, Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as well as the Pharmacokinetic Profile of 60 mg and 120 mg of GW679769 administered once daily vs Placebo in Women with Overactive Bladder
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW679769 oral tablets | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to Week 12 in the number of incontinence episodes/24 hrs | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Weeks 6 and 12 in the following endpoints: Number of micturitions/24 hrs Number of urgency episodes/24 hrs Number of nocturia episodes/24 hrs | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Huntsville | Alabama | 35801 | United States | ||
| GSK Investigational Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 9, 2017 | |
| Reset | Mar 2, 2018 | |
| Release | Mar 13, 2018 |
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| Peoria |
| Arizona |
| 85381 - 4828 |
| United States |
| GSK Investigational Site | Phoenix | Arizona | 85023 | United States |
| GSK Investigational Site | La Mesa | California | 91942 | United States |
| GSK Investigational Site | Modesto | California | 95350 | United States |
| GSK Investigational Site | San Bernardino | California | 92404 | United States |
| GSK Investigational Site | Torrance | California | 90506 | United States |
| GSK Investigational Site | Aurora | Colorado | 80012 | United States |
| GSK Investigational Site | Denver | Colorado | 80210 | United States |
| GSK Investigational Site | Denver | Colorado | 80211 | United States |
| GSK Investigational Site | Longmont | Colorado | 80501 | United States |
| GSK Investigational Site | Waterbury | Connecticut | 06708 | United States |
| GSK Investigational Site | Aventura | Florida | 33180 | United States |
| GSK Investigational Site | Clearwater | Florida | 33761 | United States |
| GSK Investigational Site | Fort Myers | Florida | 33916 | United States |
| GSK Investigational Site | Miami | Florida | 33143 | United States |
| GSK Investigational Site | Miami | Florida | 33156 | United States |
| GSK Investigational Site | Ocala | Florida | 34474 | United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| GSK Investigational Site | Sarasota | Florida | 34237 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30309 | United States |
| GSK Investigational Site | Melrose Park | Illinois | 60160 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46254 | United States |
| GSK Investigational Site | Jeffersonville | Indiana | 47130 | United States |
| GSK Investigational Site | Newburgh | Indiana | 47630 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40509 | United States |
| GSK Investigational Site | Albany | New York | 12205 | United States |
| GSK Investigational Site | Kingston | New York | 12401 | United States |
| GSK Investigational Site | Poughkeepsie | New York | 12601 | United States |
| GSK Investigational Site | Salisbury | North Carolina | 28144 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Springfield | Oregon | 97477 | United States |
| GSK Investigational Site | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| GSK Investigational Site | Lancaster | Pennsylvania | 17604 | United States |
| GSK Investigational Site | Sellersville | Pennsylvania | 18960 | United States |
| GSK Investigational Site | Providence | Rhode Island | 02906 | United States |
| GSK Investigational Site | Simpsonville | South Carolina | 29681 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37232 | United States |
| GSK Investigational Site | Dallas | Texas | 75234 | United States |
| GSK Investigational Site | Richmond | Virginia | 23294 | United States |
| GSK Investigational Site | Tacoma | Washington | 98405 | United States |
| GSK Investigational Site | Surrey | British Columbia | V3V 1N1 | Canada |
| GSK Investigational Site | Victoria | British Columbia | V8T 5G1 | Canada |
| GSK Investigational Site | Victoria | British Columbia | V8V 3N1 | Canada |
| GSK Investigational Site | Fredericton | New Brunswick | E3B 5B8 | Canada |
| GSK Investigational Site | Saint John | New Brunswick | E2L 4L2 | Canada |
| GSK Investigational Site | Kentville | Nova Scotia | B4N 4K9 | Canada |
| GSK Investigational Site | Truro | Nova Scotia | B2N 1L2 | Canada |
| GSK Investigational Site | Barrie | Ontario | L4M 7G1 | Canada |
| GSK Investigational Site | Kitchener | Ontario | N2M 5N4 | Canada |
| GSK Investigational Site | Newmarket | Ontario | L3X 1W1 | Canada |
| GSK Investigational Site | North Bay | Ontario | P1B 4Z2 | Canada |
| GSK Investigational Site | Oakville | Ontario | L6H 3P1 | Canada |
| GSK Investigational Site | Toronto | Ontario | M6A 3B5 | Canada |
| GSK Investigational Site | Greenfield Park | Quebec | J4V 2H3 | Canada |
| GSK Investigational Site | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| GSK Investigational Site | Québec | Quebec | G1S 2L6 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 9, 2017 | Mar 2, 2018 | |||
| Mar 13, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C531951 | casopitant |
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