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

This study has been terminated.

First Received: July 17, 2006 Last Updated: July 17, 2008 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00353808

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Drug Information available for: Reboxetine Reboxetine mesylate

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

Estimated Enrollment:	200
Study Start Date:	July 2006

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

Study ID Numbers:	A6061029
Study First Received:	July 17, 2006
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00353808 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuralgia, Postherpetic
Herpes Zoster
Neurotransmitter Agents
Adrenergic Agents
Neuralgia

Psychotropic Drugs
Pain
Antidepressive Agents
Reboxetine

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Therapeutic Uses

Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents
Reboxetine

ClinicalTrials.gov processed this record on September 03, 2009