PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia

May 9, 2011 updated by: Pfizer

A Four Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2A Study Of PH-797804 In The Treatment Of Post-Herpetic Neuralgia

This is a proof-of-concept study to determine if PH-797804 reduces neuropathic pain associated with post-herpetic neuralgia. Suitable patients will be randomized to receive either PH-797804 or placebo for 4 weeks, during which time they will also record their pain symptoms using various pain scales.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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

    • V Region
      • Vina del Mar, V Region, Chile, 2520997
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 123098
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 194175
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 194354
        • Pfizer Investigational Site
      • Yaroslavl, Russian Federation, 150030
        • Pfizer Investigational Site
      • Cadiz, Spain, 11009
        • Pfizer Investigational Site
      • Madrid, Spain, 28006
        • Pfizer Investigational Site
      • Ourense, Spain, 32005
        • Pfizer Investigational Site
      • Sevilla, Spain, 41013
        • Pfizer Investigational Site
      • Valencia, Spain, 46014
        • Pfizer Investigational Site
      • Linkoping, Sweden, 581 85
        • Pfizer Investigational Site
      • Stockholm, Sweden, 114 54
        • Pfizer Investigational Site
      • Stockholm, Sweden, 115 22
        • Pfizer Investigational Site
      • Dnipropetrovsk, Ukraine, 49616
        • Pfizer Investigational Site
      • Donetsk, Ukraine, 83045
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61052
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61068
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61178
        • Pfizer Investigational Site
      • Kyiv, Ukraine, 04050
        • Pfizer Investigational Site
      • Odessa, Ukraine, 65025
        • Pfizer Investigational Site
      • Simferopol, Ukraine, 95006
        • Pfizer Investigational Site
      • Solihull, United Kingdom, B91 2JL
        • Pfizer Investigational Site
    • East Sussex
      • Bexhill on Sea, East Sussex, United Kingdom, TN40 1JJ
        • Pfizer Investigational Site
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 7EN
        • Pfizer Investigational Site
    • Surrey
      • Weybridge, Surrey, United Kingdom, KT15 2BH
        • Pfizer 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, at least 18 years of age
  • Patients must have pain present for more than 3 months after healing of the Herpes zoster skin rash. There is no upper limit on the duration of PHN.
  • Patients at screening visit (V1) must have a score ≥40 mm on the Pain Visual Analog Score (VAS).

Exclusion Criteria:

  • Patients having other severe pain, which may impair the self-assessment of the pain due to post-herpetic neuralgia
  • History within the previous year of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, New York Heart Association (NYHA) Class III-IV congestive heart failure requiring treatment, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
  • Tuberculosis without treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative) without known (documented) vaccination with the bacilli Calmette-Guerin vaccine (BCG).
  • A positive approved immunoassay/ELISA blood test for TB (e.g. TB T-SPOT™, QuantiFERON-Gold
  • Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0
  • ECG abnormalities at screening or randomization
  • Evidence of organ dysfunction or hematopoietic disorder

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
6 mg dose in oral capsule form, once daily for 28 days
Placebo Comparator: 2
oral capsule form, once daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to endpoint in weekly average pain score using the 11-point daily pain rating scale
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
PH-797804 pharmacokinetics
Time Frame: Weeks 1, 2, and 4
Weeks 1, 2, and 4
Patient global impression of change
Time Frame: Week 4
Week 4
Neuropathic Pain Symptom Inventory
Time Frame: Baseline and Weeks 1, 2, and 4
Baseline and Weeks 1, 2, and 4

Collaborators and Investigators

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

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

April 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2011

Last Update Submitted That Met QC Criteria

May 9, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

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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