Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia

December 11, 2019 updated by: Pfizer

A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia

To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 3

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

  • Belgium
      • Bruxelles, Belgium, 1070
        • Pfizer Investigational Site
      • Pellenberg, Belgium, 3212
        • Pfizer Investigational Site
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • Pfizer Investigational Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Pfizer Investigational Site
    • Quebec
      • Pointe Claire, Quebec, Canada, H9R 3J1
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • Pfizer Investigational Site
  • Czechia
      • Hlucin, Czechia, 748 01
        • Pfizer Investigational Site
      • Pardubice, Czechia, 530 02
        • Pfizer Investigational Site
      • Praha 2, Czechia, 128 50
        • Pfizer Investigational Site
      • Zlin, Czechia, 760 01
        • Pfizer Investigational Site
  • France
      • Nice Cedex 1, France, 06002
        • Pfizer Investigational Site
      • Paris Cedex 04, France, 75181
        • Pfizer Investigational Site
    • Cedex
      • Lille, Cedex, France, 59037
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Pfizer Investigational Site
      • Berlin, Germany, 14109
        • Pfizer Investigational Site
      • Eichstaett, Germany, 85072
        • Pfizer Investigational Site
      • Goeppingen, Germany, 73033
        • Pfizer Investigational Site
      • Hamburg, Germany, 20095
        • Pfizer Investigational Site
      • Mannheim, Germany, 68161
        • Pfizer Investigational Site
      • Muenchen, Germany, 80336
        • Pfizer Investigational Site
      • Wiesbaden, Germany, 65189
        • Pfizer Investigational Site
  • Korea, Republic of
      • Gwangju, Korea, Republic of, 501-757
        • Pfizer Investigational Site
    • Kyeongki-do
      • Suwon-si, Kyeongki-do, Korea, Republic of, 442-712
        • Pfizer Investigational Site
  • Netherlands
      • Breda, Netherlands, 4819 EV
        • Pfizer Investigational Site
      • Emmen, Netherlands, 7824 AA
        • Pfizer Investigational Site
      • Leeuwarden, Netherlands, 8934 AD
        • Pfizer Investigational Site
  • South Africa
    • Gauteng
      • Boksburg, Gauteng, South Africa, 1462
        • Pfizer Investigational Site
    • Gauteng Province
      • Pretoria, Gauteng Province, South Africa, 0001
        • Pfizer Investigational Site
    • Western Cape
      • Panorama, Western Cape, South Africa, 7500
        • Pfizer Investigational Site
      • Parow, Western Cape, South Africa, 7500
        • Pfizer Investigational Site
  • Sweden
      • Goteborg, Sweden, 412 55
        • Pfizer Investigational Site
      • Molndal, Sweden, 431 37
        • Pfizer Investigational Site
      • Stockholm, Sweden, 115 22
        • Pfizer Investigational Site
      • Stockholm, Sweden, 182 88
        • Pfizer Investigational Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Pfizer Investigational Site
      • Colchester, United Kingdom, C04 5JL
        • Pfizer Investigational Site
      • Derby, United Kingdom, DE1 2QY
        • Pfizer Investigational Site
      • Dudley, West Midlands, United Kingdom, DY1 2HQ
        • Pfizer Investigational Site
      • Greenock, United Kingdom, PA16 0XN
        • Pfizer Investigational Site
      • Paisley, United Kingdom, PA2 7DE
        • Pfizer Investigational Site
  • United States
    • California
      • Orangevale, California, United States, 95662
        • Pfizer Investigational Site
      • Santa Ana, California, United States, 92705
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80239
        • Pfizer Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34471
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34474
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Pfizer Investigational Site
    • Illinois
      • Moline, Illinois, United States, 61265
        • Pfizer Investigational Site
    • Kansas
      • Prairie Village, Kansas, United States, 66206
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Pfizer Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • New Jersey
      • Kenilworth, New Jersey, United States, 07033
        • Pfizer Investigational Site
    • New York
      • Rochester, New York, United States, 14618
        • Pfizer Investigational Site
      • Staten Island, New York, United States, 10312
        • Pfizer Investigational Site
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Pfizer Investigational Site
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Marion, Ohio, United States, 43302
        • Pfizer Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Pfizer Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Pfizer Investigational Site
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • Pfizer Investigational Site
      • Cumberland, Rhode Island, United States, 02864
        • Pfizer Investigational Site
      • Lincoln, Rhode Island, United States, 02865
        • Pfizer Investigational Site
      • Warwick, Rhode Island, United States, 02886
        • Pfizer Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Pfizer Investigational Site
      • Charleston, South Carolina, United States, 29412
        • Pfizer Investigational Site
      • Greer, South Carolina, United States, 29651
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77063
        • Pfizer Investigational Site
      • Lake Jackson, Texas, United States, 77566
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78213
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
      • Virginia Beach, Virginia, United States, 23455
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, United States, 99216
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • 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:

  • Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)

Exclusion Criteria:

  • Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Open Label
Drug: [S,S]-reboxetine
S_S reboxetine dosed daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
12-lead ECG
Time Frame: 68 weeks
68 weeks
Hematology/Biochemistry
Time Frame: 68 weeks
68 weeks
Adverse events
Time Frame: 68 weeks
68 weeks
Physical examination
Time Frame: 68 weeks
68 weeks
Vital signs
Time Frame: 68 weeks
68 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Global Impression of Change
Time Frame: 68 weeks
68 weeks

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)

October 20, 2007

Primary Completion (ACTUAL)

May 18, 2009

Study Completion (ACTUAL)

May 18, 2009

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (ESTIMATE)

February 5, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6061046

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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