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Study of Milnacipran for the Treatment of Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
milnacipran hydrochloride
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring NSRI, milnacipran, fibromyalgia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria Exclusion Criteria: Psychiatric illness Depression Suicidal risk Substance abuse Pulmonary dysfunction Renal impairment Active cardiac disease Liver disease Autoimmune disease Cancer Sleep apnea Inflammatory bowel disease

Sites / Locations

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Outcomes

Primary Outcome Measures

Composite responder analysis based on pain and patient global status, with or without physical function.

Secondary Outcome Measures

Quality of Life
Health Assessment Questionnaire (HAQ) Disability Index
Fatigue, sleep and cognitive assessments

Full Information

First Posted
December 3, 2004
Last Updated
December 18, 2007
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00098124
Brief Title
Study of Milnacipran for the Treatment of Fibromyalgia
Official Title
A Phase III Pivotal, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Milnacipran for the Treatment of Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

5. Study Description

Brief Summary
Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
NSRI, milnacipran, fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
milnacipran hydrochloride
Primary Outcome Measure Information:
Title
Composite responder analysis based on pain and patient global status, with or without physical function.
Secondary Outcome Measure Information:
Title
Quality of Life
Title
Health Assessment Questionnaire (HAQ) Disability Index
Title
Fatigue, sleep and cognitive assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria Exclusion Criteria: Psychiatric illness Depression Suicidal risk Substance abuse Pulmonary dysfunction Renal impairment Active cardiac disease Liver disease Autoimmune disease Cancer Sleep apnea Inflammatory bowel disease
Facility Information:
Facility Name
Forest Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Forest Investigative Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Forest Investigative Site
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
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United States
Facility Name
Forest Investigative Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
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United States
Facility Name
Forest Investigative Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
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United States
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Forest Investigative Site
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Sacramento
State/Province
California
ZIP/Postal Code
95825
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United States
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Forest Investigative Site
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San Diego
State/Province
California
ZIP/Postal Code
92108
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United States
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Forest Investigative Site
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San Diego
State/Province
California
ZIP/Postal Code
92117
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United States
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Forest Investigative Site
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Santa Ana
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California
ZIP/Postal Code
92705
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United States
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Forest Investigative Site
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Spring Valley
State/Province
California
ZIP/Postal Code
91978
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United States
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Forest Investigative Site
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Torrance
State/Province
California
ZIP/Postal Code
90505
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United States
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Forest Investigative Site
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Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
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United States
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Forest Investigative Site
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Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
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United States
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Forest Investigative Site
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
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United States
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Forest Investigative Site
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Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
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United States
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Forest Investigative Site
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Trumball
State/Province
Connecticut
ZIP/Postal Code
06611
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United States
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Forest Investigative Site
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Clearwater
State/Province
Florida
ZIP/Postal Code
33761
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United States
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Forest Investigative Site
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Deland
State/Province
Florida
ZIP/Postal Code
32720
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United States
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Forest Investigative Site
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Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
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United States
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Forest Investigative Site
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Jacksonville
State/Province
Florida
ZIP/Postal Code
33216
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United States
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Forest Investigative Site
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Ocala
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Florida
ZIP/Postal Code
34471
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United States
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Forest Investigative Site
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Ormond Beach
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Florida
ZIP/Postal Code
32174
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United States
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Forest Investigative Site
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Palm Harbor
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Florida
ZIP/Postal Code
34684
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United States
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Forest Investigative Site
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Pembroke Pines
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Florida
ZIP/Postal Code
33029
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United States
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Forest Investigative Site
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Port Orange
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Florida
ZIP/Postal Code
32127
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United States
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Forest Investigative Site
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Tamarac
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Florida
ZIP/Postal Code
33321
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United States
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Forest Investigative Site
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Decatur
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Georgia
ZIP/Postal Code
30033
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United States
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Forest Investigative Site
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Honolulu
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Hawaii
ZIP/Postal Code
96814
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United States
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Forest Investigative Site
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Meridian
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Idaho
ZIP/Postal Code
83642
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United States
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Forest Investigative Site
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Chicago
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Illinois
ZIP/Postal Code
60612
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United States
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Forest Investigative Site
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Libertyville
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Illinois
ZIP/Postal Code
60048
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United States
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Forest Investigative Site
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Peoria
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Illinois
ZIP/Postal Code
61614
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United States
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Forest Investigative Site
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Evansville
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Indiana
ZIP/Postal Code
47713
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United States
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Forest Investigative Site
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Lafayette
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Indiana
ZIP/Postal Code
47904
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United States
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Wichita
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Kansas
ZIP/Postal Code
67207
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United States
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Forest Investigative Site
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Lexington
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Kentucky
ZIP/Postal Code
40509
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United States
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Forest Investigative Site
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Baltimore
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Maryland
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21237
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United States
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Columbia
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Maryland
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21045
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United States
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Forest Investigative Site
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Frederick
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Maryland
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21702
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United States
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Newton
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Massachusetts
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02462
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United States
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North Dartmouth
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Massachusetts
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02747
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United States
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Forest Investigative Site
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Kalamazoo
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Michigan
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49009
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United States
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Forest Investigative Site
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Flowood
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Mississippi
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39232
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United States
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Forest Investigative Site
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St. Louis
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Missouri
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63141
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United States
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Forest Investigative Site
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Missoula
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Montana
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59802
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United States
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Forest Investigative Site
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Cherry Hill
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New Jersey
ZIP/Postal Code
08002
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United States
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Forest Investigative Site
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Clementon
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New Jersey
ZIP/Postal Code
08021
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United States
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Forest Investigative Site
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Santa Fe
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New Mexico
ZIP/Postal Code
87505
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United States
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Forest Investigative Site
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East Syracuse
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New York
ZIP/Postal Code
13057
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United States
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Forest Investigative Site
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Great Neck
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New York
ZIP/Postal Code
11021
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United States
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Forest Investigative Site
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Rochester
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New York
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14618
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United States
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Forest Investigative Site
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Charlotte
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North Carolina
ZIP/Postal Code
28209
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United States
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Forest Investigative Site
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Fayetteville
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North Carolina
ZIP/Postal Code
28304
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United States
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Forest Investigative Site
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Hickory
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North Carolina
ZIP/Postal Code
28601
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United States
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Forest Investigative Site
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Raleigh
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North Carolina
ZIP/Postal Code
27609
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United States
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Forest Investigative Site
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Raleigh
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North Carolina
ZIP/Postal Code
27612
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United States
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Forest Investigative Site
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Winston-Salem
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North Carolina
ZIP/Postal Code
27103
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United States
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Forest Investigative Site
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Bismarck
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North Dakota
ZIP/Postal Code
58501
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United States
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Forest Investigative Site
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Marion
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Ohio
ZIP/Postal Code
43302
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United States
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Forest Investigative Site
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Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
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United States
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Forest Investigative Site
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Bend
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Oregon
ZIP/Postal Code
97701
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United States
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Forest Investigative Site
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Eugene
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Oregon
ZIP/Postal Code
97404
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United States
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Forest Investigative Site
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Medford
State/Province
Oregon
ZIP/Postal Code
97504
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United States
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Forest Investigative Site
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Portland
State/Province
Oregon
ZIP/Postal Code
97205
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United States
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Forest Investigative Site
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Duncanville
State/Province
Pennsylvania
ZIP/Postal Code
16635
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United States
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Forest Investigative Site
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Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
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United States
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Forest Investigative Site
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Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
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United States
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Forest Investigative Site
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Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
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United States
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Forest Investigative Site
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Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
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United States
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Forest Investigative Site
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Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
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United States
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Forest Investigative Site
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Austin
State/Province
Texas
ZIP/Postal Code
78705
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United States
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Forest Investigative Site
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San Antonio
State/Province
Texas
ZIP/Postal Code
78205
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United States
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Forest Investigative Site
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Sugarland
State/Province
Texas
ZIP/Postal Code
77479
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United States
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Forest Investigative Site
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Richmond
State/Province
Virginia
ZIP/Postal Code
23294
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United States
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Forest Investigative Site
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Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
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United States
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Forest Investigative Site
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Bellingham
State/Province
Washington
ZIP/Postal Code
98226
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United States
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Forest Investigative Site
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Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
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Forest Investigative Site
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Seattle
State/Province
Washington
ZIP/Postal Code
98166
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United States
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Forest Investigative Site
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
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Forest Investigative Site
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53406
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19108787
Citation
Clauw DJ, Mease P, Palmer RH, Gendreau RM, Wang Y. Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Clin Ther. 2008 Nov;30(11):1988-2004. doi: 10.1016/j.clinthera.2008.11.009. Erratum In: Clin Ther. 2009 Feb;31(2):446. Clin Ther. 2009 Jul;31(7):1617.
Results Reference
derived

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Study of Milnacipran for the Treatment of Fibromyalgia

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