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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00125892




Registration number
NCT00125892
Ethics application status
Date submitted
29/07/2005
Date registered
2/08/2005
Date last updated
17/05/2007

Titles & IDs
Public title
A Study of Duloxetine in the Treatment of Fibromyalgia
Scientific title
A 1-Year Safety Study of Duloxetine in Patients With Fibromyalgia Syndrome
Secondary ID [1] 0 0
F1J-MC-HMEH
Secondary ID [2] 0 0
9075
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - duloxetine

Treatment: Drugs: duloxetine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate safety and efficacy of duloxetine in patients diagnosed with fibromyalgia syndrome
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Evaluate persistence of efficacy
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Evaluate long-term differences in efficacy in different doses
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Evaluate gains in efficacy in non-responders
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
- Meet criteria for primary fibromyalgia syndrome as defined by the American College of
Rheumatologists
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
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
Recruitment hospital [2] 0 0
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
Recruitment hospital [3] 0 0
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
Recruitment hospital [4] 0 0
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
Recruitment postcode(s) [1] 0 0
4558 - Cotton Tree
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
- Hobart
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Capital Federal
Country [3] 0 0
Brazil
State/province [3] 0 0
Curitiba
Country [4] 0 0
Brazil
State/province [4] 0 0
Goiania
Country [5] 0 0
Brazil
State/province [5] 0 0
Recife
Country [6] 0 0
Brazil
State/province [6] 0 0
Rio de Janeiro
Country [7] 0 0
Brazil
State/province [7] 0 0
Sao Paulo
Country [8] 0 0
Canada
State/province [8] 0 0
Newfoundland and Labrador
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Saskatchewan
Country [11] 0 0
Mexico
State/province [11] 0 0
Michoacan
Country [12] 0 0
Mexico
State/province [12] 0 0
Yucatan
Country [13] 0 0
Mexico
State/province [13] 0 0
Guadalajara
Country [14] 0 0
Mexico
State/province [14] 0 0
Mexico City
Country [15] 0 0
Poland
State/province [15] 0 0
Lublin
Country [16] 0 0
Poland
State/province [16] 0 0
Poznan
Country [17] 0 0
Poland
State/province [17] 0 0
Szczecin
Country [18] 0 0
Poland
State/province [18] 0 0
Wroclaw
Country [19] 0 0
Taiwan
State/province [19] 0 0
Kaohsiung
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taichung
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taipei
Country [22] 0 0
Taiwan
State/province [22] 0 0
Tao-Yuan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Boehringer Ingelheim
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to evaluate duloxetine for the treatment of fibromyalgia syndrome
patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00125892
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00125892