NCT00673452

Brief Summary

The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
530

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_4

Geographic Reach
2 countries

46 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

First Submitted

Initial submission to the registry

May 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
12 months until next milestone

Results Posted

Study results publicly available

June 24, 2010

Completed
Last Updated

June 24, 2010

Status Verified

May 1, 2010

Enrollment Period

10 months

First QC Date

May 5, 2008

Results QC Date

April 14, 2010

Last Update Submit

May 28, 2010

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Patient's Global Impressions of Improvement (PGI-I) at Week 12

    The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is "very much improved," a score of 4 indicates that the patient has experienced "no change," and a score of 7 indicates that the patient is "very much worse."

    12 weeks

Secondary Outcomes (14)

  • Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint

    Baseline, 12 weeks

  • Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint

    Baseline, 12 weeks

  • Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint

    Baseline, 12 weeks

  • Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint

    Baseline, 12 Weeks

  • Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint

    Baseline, 12 weeks

  • +9 more secondary outcomes

Study Arms (2)

Duloxetine

EXPERIMENTAL

60-120 mg, oral, every day, 12 weeks

Drug: duloxetine hydrochloride

Placebo

PLACEBO COMPARATOR

oral, daily, 12 weeks

Drug: placebo

Interventions

duloxetine hydrochlorideDRUG

60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase).

Also known as: LY248686, Cymbalta
Duloxetine
placeboDRUG

oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female patients
  • aged 18 and older who meet criteria for fibromyalgia as defined by the American College of Rheumatology
  • have a score of at least 4 on the average pain item of the Brief Pain Inventory (BPI) (modified short form) at visits 1 and 2
  • all females must test negative for pregnancy at the time of enrollment
  • have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.

You may not qualify if:

  • have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
  • have regional pain syndrome, multiple surgeries or failed back syndrome
  • have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (46)

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

Phoenix, Arizona, 85050, United States

Location

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Tucson, Arizona, 85741, United States

Location

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Los Angeles, California, 90024, United States

Location

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Pasadena, California, 91105, United States

Location

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Cromwell, Connecticut, 06416, United States

Location

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Danbury, Connecticut, 06810, United States

Location

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Bradenton, Florida, 34208, United States

Location

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DeLand, Florida, 32720, United States

Location

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Fort Myers, Florida, 33912, United States

Location

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Orlando, Florida, 32806, United States

Location

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South Miami, Florida, 33143, United States

Location

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Tampa, Florida, 33606, United States

Location

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West Palm Beach, Florida, 33407, United States

Location

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Oak Brook, Illinois, 60523, United States

Location

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Lafayette, Indiana, 47905, United States

Location

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Prairie Village, Kansas, 66206, United States

Location

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Rockville, Maryland, 20852, United States

Location

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Belmont, Massachusetts, 02478, United States

Location

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Fall River, Massachusetts, 02721, United States

Location

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Newton, Massachusetts, 02462, United States

Location

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Springfield, Massachusetts, 01103, United States

Location

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Ann Arbor, Michigan, 48104, United States

Location

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St Louis, Missouri, 63141, United States

Location

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Edison, New Jersey, 08817, United States

Location

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Piscataway, New Jersey, 08854, United States

Location

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Greensboro, North Carolina, 27408, United States

Location

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Cincinnati, Ohio, 45219, United States

Location

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Toledo, Ohio, 43623, United States

Location

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Oklahoma City, Oklahoma, 73109, United States

Location

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Eugene, Oregon, 97404, United States

Location

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Portland, Oregon, 97210, United States

Location

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Philadelphia, Pennsylvania, 19107, United States

Location

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Myrtle Beach, South Carolina, 29572, United States

Location

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Dallas, Texas, 75231, United States

Location

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Lake Jackson, Texas, 77566, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Waco, Texas, 76708, United States

Location

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Wichita Falls, Texas, 76309, United States

Location

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West Jordan, Utah, 84088, United States

Location

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Bellevue, Washington, 98007, United States

Location

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Seattle, Washington, 98104, United States

Location

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Tacoma, Washington, 98405, United States

Location

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Middleton, Wisconsin, 53562, United States

Location

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Hato Rey, 00918, Puerto Rico

Location

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Ponce, 00716, Puerto Rico

Location

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San Juan, 00935, Puerto Rico

Location

Related Publications (3)

  • Mohs R, Mease P, Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. The effect of duloxetine treatment on cognition in patients with fibromyalgia. Psychosom Med. 2012 Jul-Aug;74(6):628-34. doi: 10.1097/PSY.0b013e31825b9855. Epub 2012 Jun 28.

    PMID: 22753629DERIVED

  • Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Improvement in multiple dimensions of fatigue in patients with fibromyalgia treated with duloxetine: secondary analysis of a randomized, placebo-controlled trial. Arthritis Res Ther. 2011 Jun 13;13(3):R86. doi: 10.1186/ar3359.

    PMID: 21668963DERIVED

  • Arnold LM, Clauw D, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Flexible dosed duloxetine in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2010 Dec;37(12):2578-86. doi: 10.3899/jrheum.100365. Epub 2010 Sep 15.

    PMID: 20843911DERIVED

Related Links

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

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 5, 2008

First Posted

May 7, 2008

Study Start

June 1, 2008

Primary Completion

April 1, 2009

Study Completion

July 1, 2009

Last Updated

June 24, 2010

Results First Posted

June 24, 2010

Record last verified: 2010-05

Locations

US(43)PR(3)