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

Tracking Information

First Received Date ^ICMJE

July 17, 2006

Last Updated Date

April 6, 2011

Start Date ^ICMJE

July 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Vital signs
Physical examination
12-lead ECG
Hematology/Biochemistry
Adverse events

Original Primary Outcome Measures ^ICMJE

Hematology/Biochemistry
Vital signs
Physical examination
12-lead ECG
Adverse events

Change History

Complete list of historical versions of study NCT00353808 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pain Visual Analogue Scale
Patient Global Impression of Change

Original Secondary Outcome Measures ^ICMJE

Pain Visual Analogue Scale
Patient Global Impression of Change

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-Label Extension Trial Assessing The Safety And Tolerability Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN).

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: [S,S]-Reboxetine

Study Arm (s)

Experimental: s, s reboxetine

Intervention: Drug: [S,S]-Reboxetine

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

112

Completion Date

October 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00353808

Other Study ID Numbers ^ICMJE

A6061029

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2011

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

To Top