[S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.

November 7, 2007 updated by: Pfizer

A Phase 2B Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Postherpetic Neuralgia (PHN).

The purpose of this study is to assess the long term (up to 2 years) safety and tolerability of [S,S]-Reboxetine in patients with pain after shingles.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

600

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

  • Argentina
      • Buenos Aires, Argentina, C1428AQK
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1280AEB
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1015ABR
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1133AAW
        • Pfizer Investigational Site
  • Canada
    • Ontario
      • Sudbury, Ontario, Canada, P3A 1Y4
        • Pfizer Investigational Site
      • Sudbury, Ontario, Canada, P3A 1Y8
        • Pfizer Investigational Site
      • Sudbury, Ontario, Canada, P3E 1H5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M3M 3E5
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3S 2W1
        • Pfizer Investigational Site
  • Chile
    • RM
      • Santiago, RM, Chile
        • Pfizer Investigational Site
    • V Región
      • Viña del Mar, V Región, Chile, 2520021
        • Pfizer Investigational Site
  • Croatia
      • Split, Croatia, 21000
        • Pfizer Investigational Site
  • India
      • Bangalore, India, 560 034
        • Pfizer Investigational Site
      • Chennai, India, 600 116
        • Pfizer Investigational Site
      • Hyderabad, India, 500 033
        • Pfizer Investigational Site
      • New Delhi, India, 110 002
        • Pfizer Investigational Site
      • New Delhi, India, 110 076
        • Pfizer Investigational Site
    • Andhra Pradhesh
      • Hyderabad, Andhra Pradhesh, India, 500 033
        • Pfizer Investigational Site
    • Punjab
      • Chandigarh, Punjab, India, 160 012
        • Pfizer Investigational Site
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Pfizer Investigational Site
      • Klaipeda, Lithuania, 92304
        • Pfizer Investigational Site
      • Panevezys, Lithuania, 35144
        • Pfizer Investigational Site
      • Siauliai, Lithuania, 76231
        • Pfizer Investigational Site
  • Mexico
    • Yucatan
      • Merida, Yucatan, Mexico, 97000
        • Pfizer Investigational Site
  • Poland
      • Sopot, Poland, 81-855
        • Pfizer Investigational Site
  • Spain
      • Ourense, Spain, 32005
        • Pfizer Investigational Site
  • Sweden
      • Stockholm, Sweden, S-141 86
        • Pfizer Investigational Site
  • United Kingdom
      • Alcester, United Kingdom, B49 5DZ
        • Pfizer Investigational Site
      • East Sussex, United Kingdom, TN40 3RJ
        • Pfizer Investigational Site
      • London, United Kingdom, SW18 4DD
        • Pfizer Investigational Site
      • London, United Kingdom, EC1A 7BE
        • Pfizer Investigational Site
      • London, United Kingdom, WC1X 8LD
        • Pfizer Investigational Site
    • East Sussex
      • Bexhill on Sea, East Sussex, United Kingdom, TN40 1JJ
        • Pfizer Investigational Site
    • Surrey
      • Addlestone, Surrey, United Kingdom, KT15 2BH
        • Pfizer Investigational Site
  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Pfizer Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Pfizer Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Pfizer Investigational Site
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78213
        • 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 healing of the shingles skin rash.
  • Patients at screening must have a score of >/=40mm on the pain visual analogue scale.

Exclusion Criteria:

  • Patients with significant hepatic impairment.
  • Patients with other severe pain, that may impair the self-assessment of pain due to postherpetic neuralgia (pain after shingles).

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: None (Open Label)

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
EQ-5D
SF-12 Health Survey
Neuropathic Pain Symptom Inventory
Modified Brief Pain Inventory - Short Form
Analgesic Treatment Satisfaction Scale
Pain-related Medication Utilization

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

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

November 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

July 18, 2006

First Submitted That Met QC Criteria

July 18, 2006

First Posted (Estimate)

July 20, 2006

Study Record Updates

Last Update Posted (Estimate)

November 8, 2007

Last Update Submitted That Met QC Criteria

November 7, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6061030

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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