A Trial Assessing The Long Term Safety And Tolerability Of [S,S]-Reboxetine In Patients With Post-Shingles Pain.

This study has been terminated.
(This study has been terminated early as the esreboxetine development program is being discontinued. There are no safety or efficacy concerns.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00353808
First received: July 17, 2006
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Pain
Drug: [S,S]-Reboxetine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension Trial Assessing The Safety And Tolerability Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN).

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Vital signs
  • Physical examination
  • 12-lead ECG
  • Hematology/Biochemistry
  • Adverse events

Secondary Outcome Measures:
  • Pain Visual Analogue Scale
  • Patient Global Impression of Change

Enrollment: 112
Study Start Date: July 2006
Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: s, s reboxetine Drug: [S,S]-Reboxetine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353808

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Pfizer Investigational Site
Chandler, Arizona, United States, 85225
Pfizer Investigational Site
Gilbert, Arizona, United States, 85234
Pfizer Investigational Site
Sun City, Arizona, United States, 85351
Pfizer Investigational Site
Tucson, Arizona, United States, 85741
United States, California
Pfizer Investigational Site
Arcadia, California, United States, 91007
Pfizer Investigational Site
Fullerton, California, United States, 92835
Pfizer Investigational Site
Irvine, California, United States, 92618
Pfizer Investigational Site
Laguna Hills, California, United States, 92653
Pfizer Investigational Site
Loma Linda, California, United States, 92354
Pfizer Investigational Site
Redondo Beach, California, United States, 90277
United States, Colorado
Pfizer Investigational Site
Boulder, Colorado, United States, 80304
United States, Florida
Pfizer Investigational Site
Clearwater, Florida, United States, 33765
Pfizer Investigational Site
Fort Myers, Florida, United States, 33912
Pfizer Investigational Site
Holly Hill, Florida, United States, 32117
Pfizer Investigational Site
Hollywood, Florida, United States, 33021
Pfizer Investigational Site
Kissimmee, Florida, United States, 34741
Pfizer Investigational Site
Largo, Florida, United States, 33770
Pfizer Investigational Site
Longwood, Florida, United States, 32779
Pfizer Investigational Site
Ocala, Florida, United States, 34471
Pfizer Investigational Site
Ormond beach, Florida, United States, 32174
Pfizer Investigational Site
Palm Beach Gardens, Florida, United States, 33418
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60610
Pfizer Investigational Site
Oak Brook, Illinois, United States, 60523
United States, Kansas
Pfizer Investigational Site
Topeka, Kansas, United States, 66606
United States, Louisiana
Pfizer Investigational Site
Ruston, Louisiana, United States, 71270
United States, Maryland
Pfizer Investigational Site
Towson, Maryland, United States, 21286
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
Pfizer Investigational Site
Brockton, Massachusetts, United States, 02301
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Pfizer Investigational Site
Independence, Missouri, United States, 64055
Pfizer Investigational Site
Kansas City, Missouri, United States, 64114
Pfizer Investigational Site
Nixa, Missouri, United States, 65714
Pfizer Investigational Site
Springfield, Missouri, United States, 65807
Pfizer Investigational Site
St Louis, Missouri, United States, 63141
United States, New York
Pfizer Investigational Site
Amherst, New York, United States, 14226
Pfizer Investigational Site
New York, New York, United States, 10003
Pfizer Investigational Site
Orchard Park, New York, United States, 14127
United States, North Carolina
Pfizer Investigational Site
Asheville, North Carolina, United States, 28806
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27607-6520
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Pfizer Investigational Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Pfizer Investigational Site
Canfield, Ohio, United States, 44406
Pfizer Investigational Site
Kettering, Ohio, United States, 45429
Pfizer Investigational Site
Youngstown, Ohio, United States, 44504
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Pfizer Investigational Site
Allentown, Pennsylvania, United States, 18103
Pfizer Investigational Site
Altoona, Pennsylvania, United States, 16602
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635-0909
United States, Tennessee
Pfizer Investigational Site
Jackson, Tennessee, United States, 38305
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
Houston, Texas, United States, 77063
Pfizer Investigational Site
Houston, Texas, United States, 77024
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23294
United States, Washington
Pfizer Investigational Site
Spokane, Washington, United States, 99204
Pfizer Investigational Site
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00353808     History of Changes
Other Study ID Numbers: A6061029
Study First Received: July 17, 2006
Last Updated: April 6, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Reboxetine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014