Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)
NCT ID: NCT01688947
Last Updated: 2014-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2012-09-30
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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V116517 - 50 mg
V116517 50-mg tablets
V116517 50-mg tablets
Taken orally twice daily
Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
V116517 - 30 mg
V116517 30-mg tablets
V116517 30-mg tablets
Taken orally twice daily
Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Pregabalin
Pregabalin capsules
Pregabalin capsules
1-2 capsules taken orally twice daily
Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Placebo
Placebo
Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Interventions
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V116517 50-mg tablets
Taken orally twice daily
V116517 30-mg tablets
Taken orally twice daily
Pregabalin capsules
1-2 capsules taken orally twice daily
Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of PHN based on history of painful dermatomal blistering rash resolving in a few weeks followed by persistent pain in the same region of ≥ 3 months duration.
Exclusion Criteria
2. Subjects who cannot or will not agree to stop all concomitant analgesic medications apart from specified protocol supplemental analgesic medications.
3. Subjects with a recent history of seizure within the past 5 years.
4. Subjects who use opioids more than 4 days per week.
5. 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.
6. Subjects with a history of suicide attempts, or subjects clinically judged by the principal investigator (PI) to be at serious risk of suicide.
7. PHN-pain-condition-specific exclusions:
* Subjects who received pain-control interventions including neurolytic blocks or neurosurgical procedures to the affected nerve or spinal cord segment, spinal cord, stimulators, or neuraxial infusion pumps.
8. Active-comparator-related exclusions:
* Subjects who are allergic to or cannot tolerate pregabalin or acetaminophen.
21 Years
90 Years
ALL
No
Sponsors
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Purdue Pharma LP
INDUSTRY
Responsible Party
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Locations
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Investigational Site
Tucson, Arizona, United States
Investigational Site
La Jolla, California, United States
Investigational Site
North Hollywood, California, United States
Investigational Site
Boca Raton, Florida, United States
Investigational Site
Bradenton, Florida, United States
Investigational Site
DeLand, Florida, United States
Investigational Site
Fort Myers, Florida, United States
Investigational Site
Lynn Haven, Florida, United States
Investigational Site
North Miami, Florida, United States
Investigational Site
Orlando, Florida, United States
Investigational Site
Oviedo, Florida, United States
Investigational Site
Palm Beach Gardens, Florida, United States
Investigational Site
Sarasota, Florida, United States
Investigational Site
St. Petersburg, Florida, United States
Investigational Site
Sunrise, Florida, United States
Investigational Site
Decatur, Georgia, United States
Investigational Site
Chicago, Illinois, United States
Investigational Site
Prairie Village, Kansas, United States
Investigational Site
New Bedford, Massachusetts, United States
Investigational Site
Bay City, Michigan, United States
Investigational Site
Bingham Farms, Michigan, United States
Investigational Site
Pinconning, Michigan, United States
Investigational Site
Las Vegas, Nevada, United States
Investigational Site
Albuquerque, New Mexico, United States
Investigational Site
Charlotte, North Carolina, United States
Investigational Site
Raleigh, North Carolina, United States
Investigational Site
Austin, Texas, United States
Investigational Site
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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VND2002
Identifier Type: -
Identifier Source: org_study_id
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