A Trial Assessing The Long Term Safety And Tolerability Of [S,S]-Reboxetine In Patients With Post-Shingles Pain.

April 6, 2011 updated by: Pfizer

An Open-Label Extension Trial Assessing The Safety And Tolerability Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN).

The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic pain following shingles. This is the extension study of Protocol A6061026.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

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
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Pfizer Investigational Site
      • Gilbert, Arizona, United States, 85234
        • Pfizer Investigational Site
      • Sun City, Arizona, United States, 85351
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85741
        • Pfizer Investigational Site
    • California
      • Arcadia, California, United States, 91007
        • Pfizer Investigational Site
      • Fullerton, California, United States, 92835
        • Pfizer Investigational Site
      • Irvine, California, United States, 92618
        • Pfizer Investigational Site
      • Laguna Hills, California, United States, 92653
        • Pfizer Investigational Site
      • Loma Linda, California, United States, 92354
        • Pfizer Investigational Site
      • Redondo Beach, California, United States, 90277
        • Pfizer Investigational Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Pfizer Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33765
        • Pfizer Investigational Site
      • Fort Myers, Florida, United States, 33912
        • Pfizer Investigational Site
      • Holly Hill, Florida, United States, 32117
        • Pfizer Investigational Site
      • Hollywood, Florida, United States, 33021
        • Pfizer Investigational Site
      • Kissimmee, Florida, United States, 34741
        • Pfizer Investigational Site
      • Largo, Florida, United States, 33770
        • Pfizer Investigational Site
      • Longwood, Florida, United States, 32779
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34471
        • Pfizer Investigational Site
      • Ormond beach, Florida, United States, 32174
        • Pfizer Investigational Site
      • Palm Beach Gardens, Florida, United States, 33418
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Pfizer Investigational Site
      • Oak Brook, Illinois, United States, 60523
        • Pfizer Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Pfizer Investigational Site
    • Louisiana
      • Ruston, Louisiana, United States, 71270
        • Pfizer Investigational Site
    • Maryland
      • Towson, Maryland, United States, 21286
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Pfizer Investigational Site
      • Brockton, Massachusetts, United States, 02301
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Pfizer Investigational Site
    • Missouri
      • Independence, Missouri, United States, 64055
        • Pfizer Investigational Site
      • Kansas City, Missouri, United States, 64114
        • Pfizer Investigational Site
      • Nixa, Missouri, United States, 65714
        • Pfizer Investigational Site
      • Springfield, Missouri, United States, 65807
        • Pfizer Investigational Site
      • St Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • New York
      • Amherst, New York, United States, 14226
        • Pfizer Investigational Site
      • New York, New York, United States, 10003
        • Pfizer Investigational Site
      • Orchard Park, New York, United States, 14127
        • Pfizer Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27607-6520
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Pfizer Investigational Site
    • Ohio
      • Canfield, Ohio, United States, 44406
        • Pfizer Investigational Site
      • Kettering, Ohio, United States, 45429
        • Pfizer Investigational Site
      • Youngstown, Ohio, United States, 44504
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Pfizer Investigational Site
      • Altoona, Pennsylvania, United States, 16602
        • Pfizer Investigational Site
      • Duncansville, Pennsylvania, United States, 16635-0909
        • Pfizer Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77024
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77063
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Pfizer Investigational Site
      • Tacoma, Washington, United States, 98405
        • 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 met the patient selection criteria for the preceding double-blind Protocol A6061026 and have completed the 16-week trial.
  • Patients at screening must have a score of >/=40mm on the pain visual analogue scale.

Exclusion Criteria:

  • Serious adverse event during the preceding double-blind Protocol A6061026 that was determined to be related to the trial medication by the Investigator.
  • Patient treatment compliance was less than 80% in the preceding double-blind Protocol A6061026.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: s, s reboxetine
Drug: [S,S]-Reboxetine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse events
Physical examination
Vital signs
12-lead ECG
Hematology/Biochemistry

Secondary Outcome Measures

Outcome Measure
Pain Visual Analogue Scale
Patient Global Impression of Change

Collaborators and Investigators

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

Sponsor

Pfizer

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

July 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

July 17, 2006

First Submitted That Met QC Criteria

July 17, 2006

First Posted (Estimate)

July 19, 2006

Study Record Updates

Last Update Posted (Estimate)

April 7, 2011

Last Update Submitted That Met QC Criteria

April 6, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6061029

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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