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The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V116517 - 50 mg | Experimental | V116517 50-mg tablets |
|
| V116517 - 30 mg | Experimental | V116517 30-mg tablets |
|
| Pregabalin | Active Comparator | Pregabalin capsules |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V116517 50-mg tablets | Drug | Taken orally twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| "Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF) | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| mBPI-SF severity of pain (parameters including average pain, worst pain, least pain, pain right now) and interference of pain (all parts of question 6) | Week 4 | |
| Neuropathic Pain Symptom Inventory (NPSI) | Week 4 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Subjects with chronic pain conditions other than PHN as their predominant pain condition, including gout, pseudo gout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area.
Subjects who cannot or will not agree to stop all concomitant analgesic medications apart from specified protocol supplemental analgesic medications.
Subjects with a recent history of seizure within the past 5 years.
Subjects who use opioids more than 4 days per week.
Subjects with clinically unstable medical conditions, including cardiac disease (unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia); respiratory disease; biliary tract disease; hypothyroidism; adrenal cortical insufficiency; or any other medical condition that in the investigator's opinion is inadequately treated and precludes entry into the study.
Subjects with a history of suicide attempts, or subjects clinically judged by the principal investigator (PI) to be at serious risk of suicide.
PHN-pain-condition-specific exclusions:
Active-comparator-related exclusions:
Other protocol specific inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Tucson | Arizona | 85704 | United States | ||
| Investigational Site |
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| V116517 30-mg tablets |
| Drug |
Taken orally twice daily |
|
| Pregabalin capsules | Drug | 1-2 capsules taken orally twice daily |
|
| Placebo | Drug | Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily |
|
| Patient Global Impression of Change (PGIC) | Week 4 |
| Supplemental Analgesic Medication Use | Over 4 weeks |
| La Jolla |
| California |
| 92037-7651 |
| United States |
| Investigational Site | North Hollywood | California | 91606 | United States |
| Investigational Site | Boca Raton | Florida | 33486 | United States |
| Investigational Site | Bradenton | Florida | 34205 | United States |
| Investigational Site | DeLand | Florida | 32720 | United States |
| Investigational Site | Fort Myers | Florida | 33916 | United States |
| Investigational Site | Lynn Haven | Florida | 32444 | United States |
| Investigational Site | North Miami | Florida | 33161 | United States |
| Investigational Site | Orlando | Florida | 32806 | United States |
| Investigational Site | Oviedo | Florida | 32765 | United States |
| Investigational Site | Palm Beach Gardens | Florida | 33410 | United States |
| Investigational Site | Sarasota | Florida | 34233 | United States |
| Investigational Site | St. Petersburg | Florida | 33716 | United States |
| Investigational Site | Sunrise | Florida | 33351 | United States |
| Investigational Site | Decatur | Georgia | 30033 | United States |
| Investigational Site | Chicago | Illinois | 60634 | United States |
| Investigational Site | Prairie Village | Kansas | 66206 | United States |
| Investigational Site | New Bedford | Massachusetts | 02740 | United States |
| Investigational Site | Bay City | Michigan | 48706 | United States |
| Investigational Site | Bingham Farms | Michigan | 48025 | United States |
| Investigational Site | Pinconning | Michigan | 48650 | United States |
| Investigational Site | Las Vegas | Nevada | 89123 | United States |
| Investigational Site | Albuquerque | New Mexico | 87108 | United States |
| Investigational Site | Charlotte | North Carolina | 28204 | United States |
| Investigational Site | Raleigh | North Carolina | 27609 | United States |
| Investigational Site | Austin | Texas | 78731 | United States |
| Investigational Site | Salt Lake City | Utah | 84106 | United States |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000595012 | 4-(3-chloro-5-(1,2-dihydroxyethyl)-2-pyridyl)-N-(5-(trifluoromethyl)-2-pyridyl)-3,6-dihydro-2H-pyridine-1-carboxamide |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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