Pain Clinical Trial
Official title:
A Phase 2, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)
Verified date | May 2014 |
Source | Purdue Pharma LP |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.
Status | Completed |
Enrollment | 105 |
Est. completion date | April 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 90 Years |
Eligibility |
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/exclusion criteria may apply. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Investigational Site | Albuquerque | New Mexico |
United States | Investigational Site | Austin | Texas |
United States | Investigational Site | Bay City | Michigan |
United States | Investigational Site | Bingham Farms | Michigan |
United States | Investigational Site | Boca Raton | Florida |
United States | Investigational Site | Bradenton | Florida |
United States | Investigational Site | Charlotte | North Carolina |
United States | Investigational Site | Chicago | Illinois |
United States | Investigational Site | Decatur | Georgia |
United States | Investigational Site | Deland | Florida |
United States | Investigational Site | Fort Myers | Florida |
United States | Investigational Site | La Jolla | California |
United States | Investigational Site | Las Vegas | Nevada |
United States | Investigational Site | Lynn Haven | Florida |
United States | Investigational Site | New Bedford | Massachusetts |
United States | Investigational Site | North Hollywood | California |
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 | Pinconning | Michigan |
United States | Investigational Site | Prairie Village | Kansas |
United States | Investigational Site | Raleigh | North Carolina |
United States | Investigational Site | Salt Lake City | Utah |
United States | Investigational Site | Sarasota | Florida |
United States | Investigational Site | St. Petersburg | Florida |
United States | Investigational Site | Sunrise | Florida |
United States | Investigational Site | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Purdue Pharma LP |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | "Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF) | Week 4 | No | |
Secondary | 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 | No | |
Secondary | Neuropathic Pain Symptom Inventory (NPSI) | Week 4 | No | |
Secondary | Patient Global Impression of Change (PGIC) | Week 4 | No | |
Secondary | Supplemental Analgesic Medication Use | Over 4 weeks | No |
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