Clinical trial NCT00797797: Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia
Official title: A Multicenter, Randomized, Open-Label, Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Milnacipran When Added to Pregabalin in the Treatment of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: fibromyalgia
milnacipran
pregabalin
treatment
Forest Research Institute
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-11-25
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.


Eligibility criteria: Inclusion Criteria:

* diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
* tolerate at least 300 mg/day of pregabalin
* have an incomplete response to pregabalin treatment

Exclusion Criteria:

* suicidal risk
* substance abuse
* pulmonary dysfunction
* renal impairment
* active cardiac disease
* liver disease
* narrow angle glaucoma
* autoimmune disease
* cancer
* inflammatory bowel disease
* unstable endocrine disease
* prostatic enlargement

Primary outcomes:
measure: Patient Global Impression of Change (PGIC) Responder Rate at End of Study
timeFrame: End of Randomized treatment period (11 weeks)
Secondary outcomes:
measure: Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study
timeFrame: Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site
state: Alabama
city: Mesa
country: United States
facility: Forest Investigative Site
state: Arizona
city: Peoria
country: United States
facility: Forest Investigative Site
state: Arizona
city: Hot Springs
country: United States
facility: Forest Investigative Site
state: Arkansas
city: Anaheim
country: United States
facility: Forest Investigative Site
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site
state: California
city: Torrance
country: United States
facility: Forest Investigative Site
state: California
city: Walnut Creek
country: United States
facility: Forest Investigative Site
state: California
city: Denver
country: United States
facility: Forest Investigative Site
state: Colorado
city: Cromwell
country: United States
facility: Forest Investigative Site
state: Connecticut
city: Danbury
country: United States
facility: Forest Investigative Site
state: Connecticut
city: Clearwater
country: United States
facility: Forest Investigative Site
state: Florida
city: Daytona Beach
country: United States
facility: Forest Investigative Site
state: Florida
city: Delray Beach
country: United States
facility: Forest Investigative Site
state: Florida
city: Fort Myers
country: United States
facility: Forest Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site
state: Florida
city: Ocala
country: United States
facility: Forest Investigative Site
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site Orl2
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site
state: Florida
city: Ormond Beach
country: United States
facility: Forest Investigative Site
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site PP1
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site PP2
state: Florida
city: Pismo Beach
country: United States
facility: Forest Investigative Site
state: Florida
city: St. Petersburg
country: United States
facility: Forest Investigative Site
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site
state: Georgia
city: Honolulu
country: United States
facility: Forest Investigative Site
state: Hawaii
city: Couer D'Alene
country: United States
facility: Forest Investigative Site
state: Idaho
city: Evansville
country: United States
facility: Forest Investigative Site
state: Indiana
city: Indianapolis
country: United States
facility: Forest Investigative Site
state: Indiana
city: Indianapolis
country: United States
facility: Forest Investigative Site
state: Indiana
city: Baltimore
country: United States
facility: Forest Investigative Site
state: Maryland
city: No. Dartmouth
country: United States
facility: Forest Investigative Site
state: Massachusetts
city: Worcester
country: United States
facility: Forest Investigative Site
state: Massachusetts
city: Jackson
country: United States
facility: Forest Investigative Site
state: Mississippi
city: St. Louis
country: United States
facility: Forest Investigative Site
state: Missouri
city: Omaha
country: United States
facility: Forest Investigative Site
state: Nebraska
city: Albuquerque
country: United States
facility: Forest Investigative Site
state: New Mexico
city: Syracuse
country: United States
facility: Forest Investigative Site
state: New York
city: Cincinnati
country: United States
facility: Forest Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Forest Investigative Site
state: Ohio
city: Eugene
country: United States
facility: Forest Investigative Site
state: Oregon
city: Medford
country: United States
facility: Forest Investigative Site
state: Oregon
city: Portland
country: United States
facility: Forest Investigative Site
state: Oregon
city: Greer
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Memphis
country: United States
facility: Forest Investigative Site
state: Tennessee
city: Houston
country: United States
facility: Forest Investigative Site
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site
state: Texas
city: Lake Jackson
country: United States
facility: Forest Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Forest Investigative Site
state: Utah
city: Salt Lake City
country: United States
facility: Forest Investigative Site
state: Utah
city: Woodstock
country: United States
facility: Forest Investigative Site
state: Vermont
city: Bellevue
country: United States
facility: Forest Investigative Site
state: Washington
city: Bellingham
country: United States
facility: Forest Investigative Site
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site SEA1
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site SEA2
state: Washington
city: Spokane
country: United States
facility: Forest Investigative Site
state: Washington
city: Racine
country: United States
facility: Forest Investigative Site
state: Wisconsin
Study officials:
affiliation: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
name: Patricia D'Astoli
role: STUDY_DIRECTOR
References: