Clinical trial NCT01688947: Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Pain
Keywords: Pain
Neuralgia, Postherpetic
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2012-09-20
Enrollment: 105
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of V116517 versus placebo.


Eligibility 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/exclusion criteria may apply.

Primary outcomes:
measure: "Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF)
timeFrame: Week 4
Secondary outcomes:
measure: 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)
timeFrame: Week 4
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Week 4
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 4
measure: Supplemental Analgesic Medication Use
timeFrame: Over 4 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Investigational Site
state: Arizona
city: La Jolla
country: United States
facility: Investigational Site
state: California
city: North Hollywood
country: United States
facility: Investigational Site
state: California
city: Boca Raton
country: United States
facility: Investigational Site
state: Florida
city: Bradenton
country: United States
facility: Investigational Site
state: Florida
city: Deland
country: United States
facility: Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Investigational Site
state: Florida
city: Lynn Haven
country: United States
facility: Investigational Site
state: Florida
city: North Miami
country: United States
facility: Investigational Site
state: Florida
city: Orlando
country: United States
facility: Investigational Site
state: Florida
city: Oviedo
country: United States
facility: Investigational Site
state: Florida
city: Palm Beach Gardens
country: United States
facility: Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Investigational Site
state: Florida
city: Sunrise
country: United States
facility: Investigational Site
state: Florida
city: Decatur
country: United States
facility: Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Investigational Site
state: Illinois
city: Prairie Village
country: United States
facility: Investigational Site
state: Kansas
city: New Bedford
country: United States
facility: Investigational Site
state: Massachusetts
city: Bay City
country: United States
facility: Investigational Site
state: Michigan
city: Bingham Farms
country: United States
facility: Investigational Site
state: Michigan
city: Pinconning
country: United States
facility: Investigational Site
state: Michigan
city: Las Vegas
country: United States
facility: Investigational Site
state: Nevada
city: Albuquerque
country: United States
facility: Investigational Site
state: New Mexico
city: Charlotte
country: United States
facility: Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Investigational Site
state: North Carolina
city: Austin
country: United States
facility: Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Investigational Site
state: Utah
Study officials:
References: