Study Stopped
This study has been terminated early as the esreboxetine development program is being discontinued. There are no safety or efficacy concerns.
A Trial Assessing The Long Term Safety And Tolerability Of [S,S]-Reboxetine In Patients With Post-Shingles Pain.
An Open-Label Extension Trial Assessing The Safety And Tolerability Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN).
1 other identifier
interventional
112
1 country
57
Brief Summary
The purpose of this study is to assess the long-term safety and tolerability of \[S,S\]-Reboxetine in patients with chronic pain following shingles. This is the extension study of Protocol A6061026.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 pain
Started Jul 2006
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 17, 2006
CompletedFirst Posted
Study publicly available on registry
July 19, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedApril 7, 2011
April 1, 2011
July 17, 2006
April 6, 2011
Conditions
Outcome Measures
Primary Outcomes (5)
Vital signs
Physical examination
12-lead ECG
Hematology/Biochemistry
Adverse events
Secondary Outcomes (2)
Pain Visual Analogue Scale
Patient Global Impression of Change
Study Arms (1)
s, s reboxetine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients must have met the patient selection criteria for the preceding double-blind Protocol A6061026 and have completed the 16-week trial.
- Patients at screening must have a score of \>/=40mm on the pain visual analogue scale.
You may not qualify if:
- Serious adverse event during the preceding double-blind Protocol A6061026 that was determined to be related to the trial medication by the Investigator.
- Patient treatment compliance was less than 80% in the preceding double-blind Protocol A6061026.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (57)
Pfizer Investigational Site
Huntsville, Alabama, 35801, United States
Pfizer Investigational Site
Chandler, Arizona, 85225, United States
Pfizer Investigational Site
Gilbert, Arizona, 85234, United States
Pfizer Investigational Site
Sun City, Arizona, 85351, United States
Pfizer Investigational Site
Tucson, Arizona, 85741, United States
Pfizer Investigational Site
Arcadia, California, 91007, United States
Pfizer Investigational Site
Fullerton, California, 92835, United States
Pfizer Investigational Site
Irvine, California, 92618, United States
Pfizer Investigational Site
Laguna Hills, California, 92653, United States
Pfizer Investigational Site
Loma Linda, California, 92354, United States
Pfizer Investigational Site
Redondo Beach, California, 90277, United States
Pfizer Investigational Site
Boulder, Colorado, 80304, United States
Pfizer Investigational Site
Clearwater, Florida, 33765, United States
Pfizer Investigational Site
Fort Myers, Florida, 33912, United States
Pfizer Investigational Site
Holly Hill, Florida, 32117, United States
Pfizer Investigational Site
Hollywood, Florida, 33021, United States
Pfizer Investigational Site
Kissimmee, Florida, 34741, United States
Pfizer Investigational Site
Largo, Florida, 33770, United States
Pfizer Investigational Site
Longwood, Florida, 32779, United States
Pfizer Investigational Site
Ocala, Florida, 34471, United States
Pfizer Investigational Site
Ormond Beach, Florida, 32174, United States
Pfizer Investigational Site
Palm Beach Gardens, Florida, 33418, United States
Pfizer Investigational Site
Chicago, Illinois, 60610, United States
Pfizer Investigational Site
Oak Brook, Illinois, 60523, United States
Pfizer Investigational Site
Topeka, Kansas, 66606, United States
Pfizer Investigational Site
Ruston, Louisiana, 71270, United States
Pfizer Investigational Site
Towson, Maryland, 21286, United States
Pfizer Investigational Site
Boston, Massachusetts, 02215, United States
Pfizer Investigational Site
Brockton, Massachusetts, 02301, United States
Pfizer Investigational Site
Ann Arbor, Michigan, 48104, United States
Pfizer Investigational Site
Independence, Missouri, 64055, United States
Pfizer Investigational Site
Kansas City, Missouri, 64114, United States
Pfizer Investigational Site
Nixa, Missouri, 65714, United States
Pfizer Investigational Site
Springfield, Missouri, 65807, United States
Pfizer Investigational Site
St Louis, Missouri, 63141, United States
Pfizer Investigational Site
Amherst, New York, 14226, United States
Pfizer Investigational Site
New York, New York, 10003, United States
Pfizer Investigational Site
Orchard Park, New York, 14127, United States
Pfizer Investigational Site
Asheville, North Carolina, 28806, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27607-6520, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103, United States
Pfizer Investigational Site
Fargo, North Dakota, 58103, United States
Pfizer Investigational Site
Canfield, Ohio, 44406, United States
Pfizer Investigational Site
Kettering, Ohio, 45429, United States
Pfizer Investigational Site
Youngstown, Ohio, 44504, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112, United States
Pfizer Investigational Site
Allentown, Pennsylvania, 18103, United States
Pfizer Investigational Site
Altoona, Pennsylvania, 16602, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635-0909, United States
Pfizer Investigational Site
Jackson, Tennessee, 38305, United States
Pfizer Investigational Site
Dallas, Texas, 75230, United States
Pfizer Investigational Site
Houston, Texas, 77024, United States
Pfizer Investigational Site
Houston, Texas, 77063, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Richmond, Virginia, 23294, United States
Pfizer Investigational Site
Spokane, Washington, 99204, United States
Pfizer Investigational Site
Tacoma, Washington, 98405, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 17, 2006
First Posted
July 19, 2006
Study Start
July 1, 2006
Study Completion
October 1, 2007
Last Updated
April 7, 2011
Record last verified: 2011-04