Brief Summary

This study is designed to evaluate duloxetine for the treatment of fibromyalgia syndrome patients.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

320

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jul 2005

Geographic Reach

7 countries

27 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

July 1, 2005

Completed

28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2005

Completed

4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed

1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed

Last Updated

May 17, 2007

Status Verified

May 1, 2007

First QC Date

July 29, 2005

Last Update Submit

May 16, 2007

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

Evaluate safety and efficacy of duloxetine in patients diagnosed with fibromyalgia syndrome

Secondary Outcomes (3)

Evaluate persistence of efficacy
Evaluate long-term differences in efficacy in different doses
Evaluate gains in efficacy in non-responders

Interventions

duloxetineDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Meet criteria for primary fibromyalgia syndrome as defined by the American College of Rheumatologists

You may not qualify if:

Treatment with a monoamine oxidase inhibitor within 14 days prior to Visit 2 or the potential need to take within 5 days after discontinuation from the study.
Any patients judged by their physicians to be at serious suicidal risk.
Have uncontrolled narrow-angle glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead
Boehringer Ingelheimcollaborator

Study Sites (27)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Buenos Aires, Argentina

Location

Capital Federal, Argentina

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician

Cotton Tree, Queensland, 4558, Australia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician

Malvern, Victoria, 3144, Australia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician

Hobart, Australia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician

Melbourne, Australia

Location

Curitiba, 80060-240, Brazil

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician

Goiânia, 74043-110, Brazil

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician

Recife, 52020-010, Brazil

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician

Rio de Janeiro, 20551-030, Brazil

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician

São Paulo, Brazil

Location

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

Location

London, Ontario, N6A 4V2, Canada

Location

Toronto, Ontario, M5T 3A9, Canada

Location

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Morelia, Michoacán, Mexico

Location

Mérida, Yucatán, Mexico

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday -Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician

Guadalajara, Mexico

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday -Friday from 9:00AM to 5:00PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician

Mexico City, Mexico

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician

Lublin, Poland

Location

For additional information regarding investigative sites for this trial. contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician

Poznan, Poland

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician

Szczecin, Poland

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician

Wroclaw, Poland

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00PM Eastern Time (UTC/GMT - 5 hours , EST) or speak with your personal physician

Kaohsiung City, Taiwan

Location

Taichung, Taiwan

Location

Taipei, Taiwan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 2, 2005

Study Start

July 1, 2005

Study Completion

March 1, 2007

Last Updated

May 17, 2007

Record last verified: 2007-05

Locations

TW(4)CA(4)AU(4)BR(5)AR(2)ME(4)PL(4)

A Study of Duloxetine in the Treatment of Fibromyalgia

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (27)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (27)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations