[S,S]-Reboxetine Dose-Range Finding Trial

June 7, 2011 updated by: Pfizer

[S,S]-Reboxetine Dose-Range Finding Trial: A 16-Week, Randomized, Double-Blind, Placebo And An Active Comparator Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN)

The purpose of this study is to determine the effectiveness of different doses of [S,S]-Reboxetine in the treatment of chronic pain following a shingles infection

Study Overview

Status

Completed

Conditions

Pain

Intervention / Treatment

Drug: [S,S]-Reboxetine

Study Type

Interventional

Enrollment

280

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
    - Pfizer Investigational Site
- Arizona
  - Chandler, Arizona, United States
    - Pfizer Investigational Site
  - Mesa, Arizona, United States
    - Pfizer Investigational Site
  - Phoenix, Arizona, United States
    - Pfizer Investigational Site
  - Sun City, Arizona, United States
    - Pfizer Investigational Site
  - Tucson, Arizona, United States
    - Pfizer Investigational Site
- Arkansas
  - Hot Springs, Arkansas, United States
    - Pfizer Investigational Site
- California
  - Arcadia, California, United States
    - Pfizer Investigational Site
  - Fullerton, California, United States
    - Pfizer Investigational Site
  - Irvine, California, United States
    - Pfizer Investigational Site
  - Laguna Hills, California, United States
    - Pfizer Investigational Site
  - Loma Linda, California, United States
    - Pfizer Investigational Site
  - Orange, California, United States
    - Pfizer Investigational Site
  - Redondo Beach, California, United States
    - Pfizer Investigational Site
  - Whittier, California, United States
    - Pfizer Investigational Site
- Colorado
  - Boulder, Colorado, United States
    - Pfizer Investigational Site
- Florida
  - Bradenton, Florida, United States
    - Pfizer Investigational Site
  - Clearwater, Florida, United States
    - Pfizer Investigational Site
  - Ft. Myers, Florida, United States
    - Pfizer Investigational Site
  - Holly Hill, Florida, United States
    - Pfizer Investigational Site
  - Hollywood, Florida, United States
    - Pfizer Investigational Site
  - Kissimmee, Florida, United States
    - Pfizer Investigational Site
  - Largo, Florida, United States
    - Pfizer Investigational Site
  - Longwood, Florida, United States
    - Pfizer Investigational Site
  - Melbourne, Florida, United States
    - Pfizer Investigational Site
  - Ocala, Florida, United States
    - Pfizer Investigational Site
  - Oviedo, Florida, United States
    - Pfizer Investigational Site
  - Palm Beach Gardens, Florida, United States
    - Pfizer Investigational Site
  - Plantation, Florida, United States
    - Pfizer Investigational Site
- Illinois
  - Chicago, Illinois, United States
    - Pfizer Investigational Site
  - Oak Brook, Illinois, United States
    - Pfizer Investigational Site
- Indiana
  - Evansville, Indiana, United States
    - Pfizer Investigational Site
- Kansas
  - Topeka, Kansas, United States
    - Pfizer Investigational Site
- Louisiana
  - Ruston, Louisiana, United States
    - Pfizer Investigational Site
- Maryland
  - Towson, Maryland, United States
    - Pfizer Investigational Site
- Massachusetts
  - Boston, Massachusetts, United States
    - Pfizer Investigational Site
  - Brockton, Massachusetts, United States
    - Pfizer Investigational Site
- Michigan
  - Ann Arbor, Michigan, United States
    - Pfizer Investigational Site
- Mississippi
  - Southaven, Mississippi, United States
    - Pfizer Investigational Site
- Missouri
  - Independence, Missouri, United States
    - Pfizer Investigational Site
  - Kansas City, Missouri, United States
    - Pfizer Investigational Site
  - Nixa, Missouri, United States
    - Pfizer Investigational Site
  - Sprinfield, Missouri, United States
    - Pfizer Investigational Site
  - St. Louis, Missouri, United States
    - Pfizer Investigational Site
- Montana
  - Billings, Montana, United States
    - Pfizer Investigational Site
- New Jersey
  - Clifton, New Jersey, United States
    - Pfizer Investigational Site
  - Hackensack, New Jersey, United States
    - Pfizer Investigational Site
  - Teaneck, New Jersey, United States
    - Pfizer Investigational Site
- New Mexico
  - Sante Fe, New Mexico, United States
    - Pfizer Investigational Site
- New York
  - Albany, New York, United States
    - Pfizer Investigational Site
  - Amherst, New York, United States
    - Pfizer Investigational Site
  - New York, New York, United States
    - Pfizer Investigational Site
  - Orchard Park, New York, United States
    - Pfizer Investigational Site
  - Rochester, New York, United States
    - Pfizer Investigational Site
- North Carolina
  - Asheville, North Carolina, United States
    - Pfizer Investigational Site
  - Raleigh, North Carolina, United States
    - Pfizer Investigational Site
  - Winston-Salem, North Carolina, United States
    - Pfizer Investigational Site
- North Dakota
  - Fargo, North Dakota, United States
    - Pfizer Investigational Site
- Ohio
  - Canfield, Ohio, United States
    - Pfizer Investigational Site
  - Cincinnati, Ohio, United States
    - Pfizer Investigational Site
  - Cleveland, Ohio, United States
    - Pfizer Investigational Site
  - Columbus, Ohio, United States
    - Pfizer Investigational Site
  - Kettering, Ohio, United States
    - Pfizer Investigational Site
  - Toledo, Ohio, United States
    - Pfizer Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States
    - Pfizer Investigational Site
- Pennsylvania
  - Allentown, Pennsylvania, United States
    - Pfizer Investigational Site
  - Altoona, Pennsylvania, United States
    - Pfizer Investigational Site
  - Duncansville, Pennsylvania, United States
    - Pfizer Investigational Site
- Tennessee
  - Jackson, Tennessee, United States
    - Pfizer Investigational Site
  - Kingsport, Tennessee, United States
    - Pfizer Investigational Site
- Texas
  - Austin, Texas, United States
    - Pfizer Investigational Site
  - Dallas, Texas, United States
    - Pfizer Investigational Site
  - Houston, Texas, United States
    - Pfizer Investigational Site
  - San Antonio, Texas, United States
    - Pfizer Investigational Site
- Virginia
  - Norfolk, Virginia, United States
    - Pfizer Investigational Site
  - Richmond, Virginia, United States
    - Pfizer Investigational Site
- Washington
  - Seattle, Washington, United States
    - Pfizer Investigational Site
  - Spokane, Washington, United States
    - Pfizer Investigational Site
  - Tacoma, Washington, 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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 significant renal and hepatic impairment
Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
Patients with clinically 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
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 14 will be calculated

Secondary Outcome Measures

Outcome Measure
- The mean endpoint (week 14) sleep interference score change from baseline - Analysis of the Medical Outcomes Study Sleep Scale - Analysis of the Patient Global Impression of Change - Analysis of the SF-36 Health Survey

Collaborators and Investigators

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

Sponsor

Pfizer

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.

Helpful Links

To obtain contact information for a study center near you, click here.

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

March 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria

February 7, 2006

First Posted (Estimate)

February 8, 2006

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 7, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A6061026

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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[S,S]-Reboxetine Dose-Range Finding Trial