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Duloxetine Versus Placebo in the Treatment of FMS

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Duloxetine

Placebo

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

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

Inclusion Criteria: meet criteria from primary FMS as defined by the ACR: widespread aching pain in all four quadrants of the body and axial skeleton and greater than or equal to 11 of 18 tender points under digital palpation examination measure average pain item of the BPI at Visits 1 and 2 Exclusion Criteria: 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) have current primary Axis I diagnosis other than major depressive disorder (MDD), including a current diagnosis of dysthymia

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Outcomes

Primary Outcome Measures

assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase

evaluate change in pain measured by Brief Pain Inventory score

evaluate endpoint of patient-reported improvement on the Patient's Global Impression of Improvement scale

Secondary Outcome Measures

change from baseline to endpoint on Sheehan Disability Scale total score

assess efficacy of duloxetine vs placebo in first 3-months of therapy measured by change in BPI average score and PGI-I endpoint

evaluate between group differences (duloxetine and placebo) in the first 3-months measured by change in baseline to endpoint in SDS total score

evaluate efficacy of duloxetine versus placebo during 6-month therapy as measured by:

FIQ

CGI-Severity

Tender-point pain thresholds

MFI

Percent of patients with 50% improvement in BPI avg. pain score

BPI Severity

evaluate duloxetine 60/120mg (QD) versus placebo during 6-month therapy as measured by the following health outcome measures:

SF-36

EQ-5D

Full Information

NCT ID

NCT00233025

First Posted

October 3, 2005

Last Updated

August 22, 2007

Sponsor

Eli Lilly and Company

Collaborators

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00233025

Brief Title

Duloxetine Versus Placebo in the Treatment of FMS

Official Title

Duloxetine 60/120mg Versus Placebo in the Treatment of Fibromyalgia Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

Collaborators

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

To test the hypothesis that the efficacy and safety of duloxetine has beneficial effects of the reduction of pain severity as measured by the average pain item of the BPI and the PGI-I in patients with fibromyalgia syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

320 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase

Title

evaluate change in pain measured by Brief Pain Inventory score

Title

evaluate endpoint of patient-reported improvement on the Patient's Global Impression of Improvement scale

Secondary Outcome Measure Information:

Title

change from baseline to endpoint on Sheehan Disability Scale total score

Title

assess efficacy of duloxetine vs placebo in first 3-months of therapy measured by change in BPI average score and PGI-I endpoint

Title

evaluate between group differences (duloxetine and placebo) in the first 3-months measured by change in baseline to endpoint in SDS total score

Title

evaluate efficacy of duloxetine versus placebo during 6-month therapy as measured by:

Title

FIQ

Title

CGI-Severity

Title

Tender-point pain thresholds

Title

MFI

Title

Percent of patients with 50% improvement in BPI avg. pain score

Title

BPI Severity

Title

evaluate duloxetine 60/120mg (QD) versus placebo during 6-month therapy as measured by the following health outcome measures:

Title

SF-36

Title

EQ-5D

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

City

Los Angeles

State/Province

California

ZIP/Postal Code

90024

Country

United States

Facility Name

City

Pasadena

State/Province

California

ZIP/Postal Code

91106

Country

United States

Facility Name

City

Cromwell

State/Province

Connecticut

ZIP/Postal Code

06416

Country

United States

Facility Name

City

Stratford

State/Province

Connecticut

ZIP/Postal Code

06615

Country

United States

Facility Name

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33709

Country

United States

Facility Name

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

City

Columbia

State/Province

Maryland

ZIP/Postal Code

21045

Country

United States

Facility Name

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73109

Country

United States

Facility Name

City

Austin

State/Province

Texas

ZIP/Postal Code

78704

Country

United States

Facility Name

City

Waco

State/Province

Texas

ZIP/Postal Code

76708

Country

United States

Facility Name

City

Bad Nenndorf

ZIP/Postal Code

31542

Country

Germany

Facility Name

City

Bad Schönborn

ZIP/Postal Code

76669

Country

Germany

Facility Name

City

Ellwangen

ZIP/Postal Code

73479

Country

Germany

Facility Name

City

Göppingen

ZIP/Postal Code

73033

Country

Germany

Facility Name

City

Itzehoe

ZIP/Postal Code

25524

Country

Germany

Facility Name

City

Planegg

ZIP/Postal Code

82152

Country

Germany

Facility Name

City

Stuttgart

ZIP/Postal Code

70176

Country

Germany

Facility Name

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28028

Country

Spain

Facility Name

City

Mostoles

ZIP/Postal Code

28935

Country

Spain

Facility Name

City

Danderyd

ZIP/Postal Code

SE-182 88

Country

Sweden

Facility Name

City

Linköping

ZIP/Postal Code

58185

Country

Sweden

Facility Name

City

Mölndal

ZIP/Postal Code

SE-431 37

Country

Sweden

Facility Name

City

Bath

State/Province

Avon

ZIP/Postal Code

BA1 1RL

Country

United Kingdom

Facility Name

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB2 2QB

Country

United Kingdom

Facility Name

City

Truro

State/Province

Cornwall

ZIP/Postal Code

TR1 3LJ

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

21312349

Citation

Mease PJ, Spaeth M, Clauw DJ, Arnold LM, Bradley LA, Russell IJ, Kajdasz DK, Walker DJ, Chappell AS. Estimation of minimum clinically important difference for pain in fibromyalgia. Arthritis Care Res (Hoboken). 2011 Jun;63(6):821-6. doi: 10.1002/acr.20449.

Results Reference

derived

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Duloxetine Versus Placebo in the Treatment of FMS

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