Pain, Postherpetic Neuralgia
Conditions
Keywords
Pain, Neuralgia, Postherpetic
Brief summary
The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.
Interventions
Taken orally twice daily
Taken orally twice daily
1-2 capsules taken orally twice daily
DRUGPlacebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Sponsors
Purdue Pharma LP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Subjects with chronic pain due to PHN as their primary pain condition and some degree of pain every day from this condition. 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. Key
Exclusion criteria
1. 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. 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. Other protocol specific inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain on the average in the last 24 hours score from the Modified Brief Pain Inventory - Short Form (mBPI-SF) | Week 4 |
Secondary
| Measure | 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 |
| Patient Global Impression of Change (PGIC) | Week 4 |
| Supplemental Analgesic Medication Use | Over 4 weeks |
Countries
United States
Outcome results
None listed