Clinical trial NCT00607256: Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia
Official title: A Multi-center, Long-term, Open-label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Fibromyalgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-05
Enrollment: 500
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: To evaluate the lon-term safety and tolerability of \[S,S\]-reboxetine in patients with fibromyalgia


Eligibility criteria: Inclusion Criteria:

* Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)

Exclusion Criteria:

* Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia

Primary outcomes:
measure: 12-lead ECG
timeFrame: 68 weeks
measure: Hematology/Biochemistry
timeFrame: 68 weeks
measure: Adverse events
timeFrame: 68 weeks
measure: Physical examination
timeFrame: 68 weeks
measure: Vital signs
timeFrame: 68 weeks
Secondary outcomes:
measure: Patient Global Impression of Change
timeFrame: 68 weeks
Other outcomes:
Locations:
city: Orangevale
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Ana
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Moline
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Prairie Village
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Jefferson City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Kenilworth
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Staten Island
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Minot
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Marion
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Medford
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Bethlehem
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Cranston
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Cumberland
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Warwick
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Anderson
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lake Jackson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Pellenberg
country: Belgium
facility: Pfizer Investigational Site
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Moncton
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: Pointe Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Hlucin
country: Czechia
facility: Pfizer Investigational Site
city: Pardubice
country: Czechia
facility: Pfizer Investigational Site
city: Praha 2
country: Czechia
facility: Pfizer Investigational Site
city: Zlin
country: Czechia
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Nice Cedex 1
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 04
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Eichstaett
country: Germany
facility: Pfizer Investigational Site
city: Goeppingen
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Mannheim
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
city: Suwon-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Kyeongki-do
city: Gwangju
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Breda
country: Netherlands
facility: Pfizer Investigational Site
city: Emmen
country: Netherlands
facility: Pfizer Investigational Site
city: Leeuwarden
country: Netherlands
facility: Pfizer Investigational Site
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng Province
city: Boksburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Panorama
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Parow
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Molndal
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Cambridge
country: United Kingdom
facility: Pfizer Investigational Site
city: Colchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Derby
country: United Kingdom
facility: Pfizer Investigational Site
city: Dudley, West Midlands
country: United Kingdom
facility: Pfizer Investigational Site
city: Greenock
country: United Kingdom
facility: Pfizer Investigational Site
city: Paisley
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: