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This is a two-part study in which Part A will assess the effects of GW679769 after 1 dose on the function of the nerves that supply the bladder. The technique for measuring the nerves function is called Neurometry. Part B will assess the effect of repeat doses of GW679769 on the bladder nerve function. Part B will also assess the effects of the drug on overactive bladder symptoms using a three-day patient diary.
A randomized, double-blind, placebo-controlled study to evaluate the effects of GW679769 on Current Perception Threshold (CPT) following a single 150 mg dose (Part A) and to evaluate the effect of CPT and symptoms of overactive bladder following 28 days of repeat dosing with 120 mg GW679769 administered once daily (Part B) in patients with neurogenic bladder due to incomplete spinal cord injury
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW679769 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bladder nerve activity assessed by neurometry before and after a single dose of GW679769 and placebo (part A) and after 28 days of drug or placebo treatment (part B). |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of OAB symptoms (incontinence, frequency of urination, reduction in urgency, decrease in night-time urination episodes). |
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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 | Long Beach | California | 90806 | United States | ||
| GSK Investigational Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 9, 2017 | |
| Reset | Feb 23, 2018 | |
| Release | Mar 8, 2018 |
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| Cleveland |
| Ohio |
| 44195 |
| United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 9, 2017 | Feb 23, 2018 | |||
| Mar 8, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D013119 | Spinal Cord Injuries |
| D053202 | Urinary Incontinence, Urge |
| 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 |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
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| ID | Term |
|---|---|
| C531951 | casopitant |
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