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Study halted prior to enrollment of patients
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The purpose of this study is to determine the effect of GSK598809 as compared to placebo in preventing recently-quit smokers from going back to smoking.
The primary objective of this study is to evaluate the efficacy of GSK598809 compared to placebo for the prevention of relapse to smoking in recently abstinent smokers. Subjects who meet eligibility criteria will enter a 4-week open label treatment period during which they will receive nicotine replacement therapy (NRT). Subjects who have achieved at least one week of abstinence during the last week of an open label treatment period will be randomized to either GSK598809 or placebo in the double-blind treatment period and followed for another 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Arm | Placebo Comparator | Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16. |
|
| GSK598809 Arm | Experimental | Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK598809 | Drug | GSK598809 once daily for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous smoking abstinence | weeks 13 through 16 |
| Measure | Description | Time Frame |
|---|---|---|
| safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events | weeks 1 through 16 and follow-up phase | |
| Weekly point prevalence abstinence | Weeks 6, 8, 10, 12, 14, and 16 |
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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 | DeLand | Florida | 32720 | United States | ||
| GSK Investigational Site |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000594007 | GSK598809 |
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| Nicotine Replacement Transdermal Patch |
| Drug |
All subjects will be treated during the 4 week open-label smoking cessation phase of the study. During Weeks 1-3, subjects will receive 21mg/day, and during Week 4, subjects will receive 14 mg/day. Those subjects who reached continuous abstinence on at least week 4 of the open-label phase will receive 7mg/day during Week 5 while taking GSK598809 or placebo. |
|
| Placebo | Drug | Placebo once daily for 12 weeks |
|
| drug exposure level | weeks 6-16 |
| Pembroke Pines |
| Florida |
| 33024 |
| United States |
| GSK Investigational Site | Stockbridge | Georgia | 30281 | United States |
| GSK Investigational Site | Overland Park | Kansas | 66211 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89104 | United States |
| GSK Investigational Site | Rochester | New York | 14609 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27612 | United States |
| GSK Investigational Site | Portland | Oregon | 97239 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| GSK Investigational Site | Dallas | Texas | 75234 | United States |