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

May 9, 2014 updated by: Purdue Pharma LP

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Investigational Site
    • California
      • La Jolla, California, United States, 92037-7651
        • Investigational Site
      • North Hollywood, California, United States, 91606
        • Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Investigational Site
      • Bradenton, Florida, United States, 34205
        • Investigational Site
      • Deland, Florida, United States, 32720
        • Investigational Site
      • Fort Myers, Florida, United States, 33916
        • Investigational Site
      • Lynn Haven, Florida, United States, 32444
        • Investigational Site
      • North Miami, Florida, United States, 33161
        • Investigational Site
      • Orlando, Florida, United States, 32806
        • Investigational Site
      • Oviedo, Florida, United States, 32765
        • Investigational Site
      • Palm Beach Gardens, Florida, United States, 33410
        • Investigational Site
      • Sarasota, Florida, United States, 34233
        • Investigational Site
      • St. Petersburg, Florida, United States, 33716
        • Investigational Site
      • Sunrise, Florida, United States, 33351
        • Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Investigational Site
    • Kansas
      • Prairie Village, Kansas, United States, 66206
        • Investigational Site
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • Investigational Site
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Investigational Site
      • Bingham Farms, Michigan, United States, 48025
        • Investigational Site
      • Pinconning, Michigan, United States, 48650
        • Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
EXPERIMENTAL: V116517 - 50 mg
V116517 50-mg tablets
Drug: V116517 50-mg tablets
Taken orally twice daily
Drug: Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
EXPERIMENTAL: V116517 - 30 mg
V116517 30-mg tablets
Drug: Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Drug: V116517 30-mg tablets
Taken orally twice daily
ACTIVE_COMPARATOR: Pregabalin
Pregabalin capsules
Drug: Placebo
Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
Drug: Pregabalin capsules
1-2 capsules taken orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
"Pain on the average in the last 24 hours" score from the Modified Brief Pain Inventory - Short Form (mBPI-SF)
Time Frame: Week 4
Week 4

Secondary Outcome Measures

Outcome 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)
Time Frame: Week 4
Week 4
Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: Week 4
Week 4
Patient Global Impression of Change (PGIC)
Time Frame: Week 4
Week 4
Supplemental Analgesic Medication Use
Time Frame: Over 4 weeks
Over 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue Pharma LP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (ESTIMATE)

September 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VND2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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