[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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 22, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2006

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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