Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia

March 27, 2007 updated by: Pfizer

A Multi-Center, Randomized, Double Blind, Dose-Response, Placebo And Gabapentin Controlled Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia

The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of chronic pain following a shingles infection.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

315

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

        • Pfizer Investigational Site
      • Woodville, Australia
        • Pfizer Investigational Site
    • New South Wales
      • Warrawong, New South Wales, Australia
        • Pfizer Investigational Site
      • Westmead, New South Wales, Australia
        • Pfizer Investigational Site
    • Queensland
      • Kippa Ring, Queensland, Australia
        • Pfizer Investigational Site
      • Maroochydore, Queensland, Australia
        • Pfizer Investigational Site
    • South Australia
      • Bedford Park, South Australia, Australia
        • Pfizer Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia
        • Pfizer Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Pfizer Investigational Site
    • Ontario
      • Toronto, Ontario, Canada
        • Pfizer Investigational Site
    • Quebec
      • Sherbrooke, Quebec, Canada
        • Pfizer Investigational Site
      • Ste-foy, Quebec, Canada
        • Pfizer Investigational Site
      • Brno, Czech Republic
        • Pfizer Investigational Site
      • CZ-Praha 8, Czech Republic
        • Pfizer Investigational Site
      • Ceske Budejovice, Czech Republic
        • Pfizer Investigational Site
      • Plzen, Czech Republic
        • Pfizer Investigational Site
      • Praha 5, Czech Republic
        • Pfizer Investigational Site
      • Arnhem, Netherlands
        • Pfizer Investigational Site
      • Breda, Netherlands
        • Pfizer Investigational Site
      • Kampen, Netherlands
        • Pfizer Investigational Site
      • Roosendaal, Netherlands
        • Pfizer Investigational Site
      • Rotterdam, Netherlands
        • Pfizer Investigational Site
      • Stadskanaal, Netherlands
        • Pfizer Investigational Site
      • Barcelona, Spain
        • Pfizer Investigational Site
      • Granada, Spain
        • Pfizer Investigational Site
      • Madrid, Spain
        • Pfizer Investigational Site
      • Malaga, Spain
        • Pfizer Investigational Site
      • Sevilla, Spain
        • Pfizer Investigational Site
      • London, United Kingdom
        • Pfizer Investigational Site
    • Hants
      • Portsmouth, Hants, United Kingdom
        • Pfizer Investigational Site
    • Northants
      • Northampton, Northants, United Kingdom
        • 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:

  • Patients must have pain present for more than 3 months after the healing of shingles skin rash.
  • Patients at screening must have a score >=40 mm on the pain visual analogue scale.

Exclusion Criteria:

  • Patients with poor renal function.
  • Patients with other severe pain, that may impair the self-assessment of the pain due to shingles.
  • Patients with abnormal electrocardiogram.

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To characterise the effectiveness of PD-217,014 in the treatment of chronic pain. A numerical pain intensity rating scale is used to assess pain and a mean endpoint (week 4) pain score change from baseline is calculated.

Secondary Outcome Measures

Outcome Measure
- Assess the effect of PD-217,014 on responder rate based on the primary endpoint, mean endpoint sleep interference score and the SF-McGill questionnaire (change from baseline to week 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

February 1, 2004

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

March 28, 2007

Last Update Submitted That Met QC Criteria

March 27, 2007

Last Verified

March 1, 2007

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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