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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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00353808
First received: July 17, 2006
Last updated: April 6, 2011
Last verified: April 2011
History of Changes
  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:

MedlinePlus related topics: Shingles
U.S. FDA Resources

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

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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:
Neuralgia, Postherpetic
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
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 May 19, 2013