Clinical trial NCT00353808: A Trial Assessing The Long Term Safety And Tolerability Of [S,S]-Reboxetine In Patients With Post-Shingles Pain.
Official title: An Open-Label Extension Trial Assessing The Safety And Tolerability Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-07-19
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Vital signs
measure: Physical examination
measure: 12-lead ECG
measure: Hematology/Biochemistry
measure: Adverse events
Secondary outcomes:
measure: Pain Visual Analogue Scale
measure: Patient Global Impression of Change
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Gilbert
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Sun City
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Arcadia
country: United States
facility: Pfizer Investigational Site
state: California
city: Fullerton
country: United States
facility: Pfizer Investigational Site
state: California
city: Irvine
country: United States
facility: Pfizer Investigational Site
state: California
city: Laguna Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Loma Linda
country: United States
facility: Pfizer Investigational Site
state: California
city: Redondo Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Boulder
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Holly Hill
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Largo
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Longwood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ormond beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Beach Gardens
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Oak Brook
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Topeka
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Ruston
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Towson
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Brockton
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Independence
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Nixa
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Amherst
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Orchard Park
country: United States
facility: Pfizer Investigational Site
state: New York
city: Asheville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Canfield
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Kettering
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Youngstown
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Altoona
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: