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

July 17, 2006
April 6, 2011
July 2006
Not Provided
  • Vital signs
  • Physical examination
  • 12-lead ECG
  • Hematology/Biochemistry
  • Adverse events
  • Hematology/Biochemistry
  • Vital signs
  • Physical examination
  • 12-lead ECG
  • Adverse events
Complete list of historical versions of study NCT00353808 on ClinicalTrials.gov Archive Site
  • Pain Visual Analogue Scale
  • Patient Global Impression of Change
  • Pain Visual Analogue Scale
  • Patient Global Impression of Change
Not Provided
Not Provided
 
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).

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
Drug: [S,S]-Reboxetine
Experimental: s, s reboxetine
Intervention: Drug: [S,S]-Reboxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
112
October 2007
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00353808
A6061029
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP