Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic Neuralgia

January 20, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Double-Blind Randomized Placebo-Controlled Trial of the Time to Onset of Pain Relief in Subjects With Post Therapeutic Neuralgia (PHN) Treated With Pregabalin (150 - 600 Mg/Day Flexible Optimized Dose or 300 Mg/Day Fixed Dose) or Placebo

The purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

255

Phase

  • Phase 4

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

  • Germany
      • Berlin, Germany
        • Pfizer Investigational Site
      • Bochum, Germany
        • Pfizer Investigational Site
      • Duesseldorf, Germany
        • Pfizer Investigational Site
      • Frankfurt, Germany
        • Pfizer Investigational Site
      • Goeppingen, Germany
        • Pfizer Investigational Site
      • Hamburg, Germany
        • Pfizer Investigational Site
      • Hattingen, Germany
        • Pfizer Investigational Site
      • Jena, Germany
        • Pfizer Investigational Site
      • Nuernberg, Germany
        • Pfizer Investigational Site
      • Wiesbaden, Germany
        • Pfizer Investigational Site
  • Italy
      • L'Aquila, Italy
        • Pfizer Investigational Site
      • Perugia, Italy
        • Pfizer Investigational Site
      • Pisa, Italy
        • Pfizer Investigational Site
      • Roma, Italy
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain
        • Pfizer Investigational Site
      • Granada, Spain
        • Pfizer Investigational Site
      • Salamanca, Spain
        • Pfizer Investigational Site
      • Sevilla, Spain
        • Pfizer Investigational Site
      • Valencia, Spain
        • Pfizer Investigational Site
    • Madrid
      • Leganes, Madrid, Spain
        • Pfizer Investigational Site
  • United Kingdom
      • Glasgow, United Kingdom
        • Pfizer Investigational Site
      • Oldham, Lancashire, United Kingdom
        • Pfizer Investigational Site
      • Portsmouth, United Kingdom
        • Pfizer Investigational Site
    • Cleveland
      • Middlesbrough, Cleveland, United Kingdom
        • Pfizer Investigational Site
    • Surrey
      • Addlestone, Surrey, United Kingdom
        • Pfizer Investigational Site
    • Sussex
      • Chicester, Sussex, United Kingdom
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Pfizer Investigational Site
    • California
      • Duarte, California, United States
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • Pfizer Investigational Site
    • Florida
      • Palm Beach Gardens, Florida, United States
        • Pfizer Investigational Site
    • Illinois
      • Oak Brook, Illinois, United States
        • Pfizer Investigational Site
    • Mississippi
      • Flowood, Mississippi, United States
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States
        • Pfizer Investigational Site
    • Ohio
      • Toledo, Ohio, United States
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of PHN with pain present for at least three months after the healing of a Herpes Zoster skin lesion.
  • Subjects must have completed the Daily Pain Rating Scale in the electronic diary at least 4 times during screening and have an average daily pain rating score of greater than or equl to 4 during the 7 +/- 3 days prior to randomization (Visit 2).

Exclusion Criteria:

  • History of neurolytic or neurosurgical therapy for PHN.
  • Presence of any severe pain associated with conditions other than PHN that may confound the assessment or self-evaluation of the pain due to PHN.

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
Onset meaningful pain reduction

Collaborators and Investigators

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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

General Publications

Helpful Links

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

October 1, 2004

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081004

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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