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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:
ClinicalTrials.gov Identifier:
NCT00353808
First Posted: July 19, 2006
Last Update Posted: April 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353808


  Show 57 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00353808     History of Changes
Other Study ID Numbers: A6061029
First Submitted: July 17, 2006
First Posted: July 19, 2006
Last Update Posted: April 7, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Reboxetine
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs