Clinical trial NCT00354094: [S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.
Official title: A Phase 2B Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Postherpetic Neuralgia (PHN).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the long term (up to 2 years) safety and tolerability of \[S,S\]-Reboxetine in patients with pain after shingles.


Eligibility criteria: Inclusion Criteria:

* Patients must have pain present for more than 3 months after healing of the shingles skin rash.
* Patients at screening must have a score of \>/=40mm on the pain visual analogue scale.

Exclusion Criteria:

* Patients with significant hepatic impairment.
* Patients with other severe pain, that may impair the self-assessment of pain due to postherpetic neuralgia (pain after shingles).

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
measure: Neuropathic Pain Symptom Inventory
measure: Modified Brief Pain Inventory - Short Form
measure: SF-12 Health Survey
measure: EQ-5D
measure: Analgesic Treatment Satisfaction Scale
measure: Pain-related Medication Utilization
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Greensboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Cumberland
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Sudbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Viña del Mar
country: Chile
facility: Pfizer Investigational Site
state: V Región
city: Split
country: Croatia
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradhesh
city: Chandigarh
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Bangalore
country: India
facility: Pfizer Investigational Site
city: Chennai
country: India
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Klaipeda
country: Lithuania
facility: Pfizer Investigational Site
city: Panevezys
country: Lithuania
facility: Pfizer Investigational Site
city: Siauliai
country: Lithuania
facility: Pfizer Investigational Site
city: Merida
country: Mexico
facility: Pfizer Investigational Site
state: Yucatan
city: Sopot
country: Poland
facility: Pfizer Investigational Site
city: Ourense
country: Spain
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Bexhill on Sea
country: United Kingdom
facility: Pfizer Investigational Site
state: East Sussex
city: Addlestone
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Alcester
country: United Kingdom
facility: Pfizer Investigational Site
city: East Sussex
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: