[S,S]-Reboxetine Add-On Trial

December 12, 2019 updated by: Pfizer

[S,S]-Reboxetine Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN) Concomitantly Treated With Pregabalin.

The purpose of this study is to determine the effectiveness of adjunctive treatment of pregabalin with [S,S]-Reboxetine against pregabalin monotherapy in patients with PHN

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

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

  • Austria
      • Wien, Austria, A - 1090
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1V 4X7
        • Pfizer Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T3E 0C5
        • Pfizer Investigational Site
      • Calgary, Alberta, Canada, T3C 3P1
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T5A 4L8
        • Pfizer Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • Pfizer Investigational Site
      • Langley, British Columbia, Canada, V3A 4H9
        • Pfizer Investigational Site
    • Ontario
      • Hawkesbury, Ontario, Canada, K6A 1A1
        • Pfizer Investigational Site
      • North Bay, Ontario, Canada, P1B 2H3
        • Pfizer Investigational Site
      • Sudbury, Ontario, Canada, P3E 1H5
        • Pfizer Investigational Site
      • Sudbury, Ontario, Canada, K3E 3L6
        • Pfizer Investigational Site
      • Val Caron, Ontario, Canada, P3N 1G3
        • Pfizer Investigational Site
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Pfizer Investigational Site
      • St-Romuald, Quebec, Canada, G6W 5M6
        • Pfizer Investigational Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 3X1
        • Pfizer Investigational Site
      • Saskatoon, Saskatchewan, Canada, S7K 7H9
        • Pfizer Investigational Site
      • Sasktatoon, Saskatchewan, Canada, S7K 6Y6
        • Pfizer Investigational Site
  • Czechia
      • Ceske Budejovice, Czechia, 370 87
        • Pfizer Investigational Site
      • Plzen, Czechia, 304 60
        • Pfizer Investigational Site
  • Germany
      • Erbach, Germany, 64711
        • Pfizer Investigational Site
      • Hattingen, Germany, 45525
        • Pfizer Investigational Site
      • Jena, Germany, 07743
        • Pfizer Investigational Site
      • Karlsruhe, Germany, 76199
        • Pfizer Investigational Site
      • Katzhuette, Germany, 98746
        • Pfizer Investigational Site
      • Mainz, Germany, 55101
        • Pfizer Investigational Site
      • Mainz, Germany, 55116
        • Pfizer Investigational Site
      • Muenchen, Germany, 81675
        • Pfizer Investigational Site
      • Muenster, Germany, 48129
        • Pfizer Investigational Site
      • Wiesbaden, Germany, 65189
        • Pfizer Investigational Site
  • Italy
      • Milano, Italy, 20127
        • Pfizer Investigational Site
      • Napoli, Italy, 80138
        • Pfizer Investigational Site
      • Perugia, Italy, 06123
        • Pfizer Investigational Site
  • Latvia
      • Riga, Latvia, LV 1002
        • Pfizer Investigational Site
  • Netherlands
      • Breda, Netherlands, 4819 EV
        • Pfizer Investigational Site
      • Utrecht, Netherlands, 3584 CX
        • Pfizer Investigational Site
  • Norway
      • Bekkestua, Norway, 1319
        • Pfizer Investigational Site
      • Lierskogen, Norway, N-3421
        • Pfizer Investigational Site
      • Oslo, Norway, 0027
        • Pfizer Investigational Site
      • Sandnes, Norway, 4313
        • Pfizer Investigational Site
      • Trondheim, Norway, 7031
        • Pfizer Investigational Site
  • Poland
      • Krakow, Poland, 31-531
        • Pfizer Investigational Site
      • Poznan, Poland, 61-289
        • Pfizer Investigational Site
  • Russian Federation
      • St. Petersburg, Russian Federation, 194044
        • Pfizer Investigational Site
      • Yaroslavl, Russian Federation, 150030
        • Pfizer Investigational Site
  • Spain
      • Cadiz, Spain, 11009
        • Pfizer Investigational Site
      • Granada, Spain, 18014
        • Pfizer Investigational Site
      • Madrid, Spain, 28006
        • Pfizer Investigational Site
      • Sevilla, Spain, 41013
        • Pfizer Investigational Site
      • Valencia, Spain, 46014
        • Pfizer Investigational Site
    • Barcelona
      • L'hospitalet de Llobregat, Barcelona, Spain, 08907
        • Pfizer Investigational Site
  • Sweden
      • Eksjo, Sweden, 575 81
        • Pfizer Investigational Site
      • Goteborg, Sweden, 416 85
        • Pfizer Investigational Site
      • Goteborg, Sweden, 413 45
        • Pfizer Investigational Site
      • Karlstad, Sweden, 651 85
        • Pfizer Investigational Site
      • Skelleftea, Sweden, 931 86
        • Pfizer Investigational Site
      • Stockholm, Sweden, 114 54
        • Pfizer Investigational Site
  • Switzerland
      • Zurich, Switzerland, 8008
        • Pfizer Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49616
        • Pfizer Investigational Site
      • Donetsk, Ukraine, 83045
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61068
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61178
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61018
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 310057
        • Pfizer Investigational Site
      • Kyiv, Ukraine, 01021
        • Pfizer Investigational Site
      • Kyiv, Ukraine, 04112
        • Pfizer Investigational Site
      • Odessa, Ukraine, 65025
        • Pfizer Investigational Site
      • Simferopol, Ukraine, 95006
        • Pfizer Investigational Site
      • Uzhgorod, Ukraine, 88011
        • Pfizer Investigational Site
  • United Kingdom
      • Glasgow, United Kingdom, G42 9YU
        • Pfizer Investigational Site
      • London, United Kingdom, EC1A 7BE
        • Pfizer Investigational Site
      • Manchester, United Kingdom, M8 5RB
        • Pfizer Investigational Site
      • Plymouth, United Kingdom, PL6 8DH
        • Pfizer Investigational Site
      • York, United Kingdom, YO31 8HE
        • Pfizer Investigational Site
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO3 6AD
        • Pfizer Investigational Site
    • UK
      • London, UK, United Kingdom, SE13 6LH
        • Pfizer Investigational Site
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B29 6JD
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Pfizer Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • New York
      • Amherst, New York, United States, 14226
        • Pfizer Investigational Site
      • Orchard Park, New York, United States, 14127
        • Pfizer Investigational Site
    • Ohio
      • Kettering, Ohio, United States, 45429
        • 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 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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pregabalin
Drug: Pregabalin
Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks
Experimental: [S,S]-Reboxetine + Pregabalin
Drug: [S,S]-Reboxetine + Pregabalin
[S,S]-Reboxetine oral, tablet 2, 4 or 6 mg per day for 10 weeks Pregabalin oral, capsule, 75, 150, 300 or 600 mg per day for 14 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 10 will be calculated
Time Frame: Week 10
Week 10

Secondary Outcome Measures

Outcome Measure
Time Frame
The mean endpoint (week 10) sleep interference score change from baseline
Time Frame: Week 10
Week 10
Analysis of the Medical Outcomes Study Sleep Scale
Time Frame: Week 10
Week 10
Analysis of the Patient Global Impression of Change
Time Frame: Week 10
Week 10
Analysis of the Neuropathic Pain Symptom Inventory
Time Frame: Week 10
Week 10

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 (Actual)

August 22, 2006

Primary Completion (Actual)

October 4, 2007

Study Completion (Actual)

October 11, 2007

Study Registration Dates

First Submitted

June 7, 2006

First Submitted That Met QC Criteria

June 7, 2006

First Posted (Estimate)

June 8, 2006

Study Record Updates

Last Update Posted (Actual)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6061021

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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