Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.

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)

Conditions
-----------------
Postherpetic Neuralgia, Pain

Intervention / Treatment
-----------------
* Drug: V116517 50-mg tablets
* Drug: V116517 30-mg tablets
* Drug: Pregabalin capsules
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Subjects with chronic pain due to PHN as their primary pain condition and some degree of pain every day from this condition. 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: 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: 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. Active-comparator-related exclusions: Subjects who are allergic to or cannot tolerate pregabalin or acetaminophen. Other protocol specific inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V116517 - 50 mg<br>V116517 50-mg tablets | Drug: V116517 50-mg tablets<br>* Taken orally twice daily<br>Drug: Placebo<br>* Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily<br>|
| Experimental: V116517 - 30 mg<br>V116517 30-mg tablets | Drug: V116517 30-mg tablets<br>* Taken orally twice daily<br>Drug: Placebo<br>* Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily<br>|
| Active Comparator: Pregabalin<br>Pregabalin capsules | Drug: Pregabalin capsules<br>* 1-2 capsules taken orally twice daily<br>Drug: Placebo<br>* Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Patient Global Impression of Change (PGIC) |  | Week 4 | 
| Supplemental Analgesic Medication Use |  | Over 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Neuralgia, Postherpetic