Clinical trial NCT00334685: [S,S]-Reboxetine Add-On Trial
Official title: [S,S]-Reboxetine Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN) Concomitantly Treated With Pregabalin.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-06-08
Enrollment: 136
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 determine the effectiveness of adjunctive treatment of pregabalin with \[S,S\]-Reboxetine against pregabalin monotherapy in patients with PHN


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients with significant renal and hepatic impairment
* Patients with other severe pain, that may impair the self-assessment of the pain due to shingles
* Patients with clinically abnormal electrocardiogram

Primary outcomes:
measure: The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 10 will be calculated
timeFrame: Week 10
Secondary outcomes:
measure: The mean endpoint (week 10) sleep interference score change from baseline
timeFrame: Week 10
measure: Analysis of the Medical Outcomes Study Sleep Scale
timeFrame: Week 10
measure: Analysis of the Patient Global Impression of Change
timeFrame: Week 10
measure: Analysis of the Neuropathic Pain Symptom Inventory
timeFrame: Week 10
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Gilbert
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: North Dartmouth
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Amherst
country: United States
facility: Pfizer Investigational Site
state: New York
city: Orchard Park
country: United States
facility: Pfizer Investigational Site
state: New York
city: Kettering
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Langley
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Hawkesbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: North Bay
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: Val Caron
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Pointe-Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St-Romuald
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Regina
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Sasktatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Ceske Budejovice
country: Czechia
facility: Pfizer Investigational Site
city: Plzen
country: Czechia
facility: Pfizer Investigational Site
city: Erbach
country: Germany
facility: Pfizer Investigational Site
city: Hattingen
country: Germany
facility: Pfizer Investigational Site
city: Jena
country: Germany
facility: Pfizer Investigational Site
city: Karlsruhe
country: Germany
facility: Pfizer Investigational Site
city: Katzhuette
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Perugia
country: Italy
facility: Pfizer Investigational Site
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Breda
country: Netherlands
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Bekkestua
country: Norway
facility: Pfizer Investigational Site
city: Lierskogen
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Sandnes
country: Norway
facility: Pfizer Investigational Site
city: Trondheim
country: Norway
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Pfizer Investigational Site
city: L'hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Cadiz
country: Spain
facility: Pfizer Investigational Site
city: Granada
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Eksjo
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Karlstad
country: Sweden
facility: Pfizer Investigational Site
city: Skelleftea
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Zurich
country: Switzerland
facility: Pfizer Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Donetsk
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Odessa
country: Ukraine
facility: Pfizer Investigational Site
city: Simferopol
country: Ukraine
facility: Pfizer Investigational Site
city: Uzhgorod
country: Ukraine
facility: Pfizer Investigational Site
city: Portsmouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Hampshire
city: London
country: United Kingdom
facility: Pfizer Investigational Site
state: UK
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
state: West Midlands
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Plymouth
country: United Kingdom
facility: Pfizer Investigational Site
city: York
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: