Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
236 participants
INTERVENTIONAL
2007-01-31
2008-10-31
Brief Summary
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Whether duloxetine once daily can help patients with Chronic Low Back Pain.
Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Duloxetine
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
Duloxetine
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
Placebo
every day (QD), by mouth (PO), 13 weeks
Placebo
every day (QD), by mouth (PO), 13 weeks
Interventions
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Duloxetine
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
Placebo
every day (QD), by mouth (PO), 13 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females of child bearing potential must test negative on a pregnancy test at visit 1.
Exclusion Criteria
* Problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions
* Psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study
* Have acute liver injury (such as hepatitis) or severe cirrhosis
* Have had previous exposure to duloxetine
* Have a body mass index (BMI) over 40
* Have a major depressive disorder
* Require daily narcotics
* Have suicidal risk
* Have a presence of any factors/conditions, medical or other, that in the judgment of the investigator may interfere with performance of study outcome measures
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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 p
Curitiba, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Amiens, , France
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Marseille, , France
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Paris, , France
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Saint-Affrique, , France
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Saint-Etienne, , France
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Ellwangen, , Germany
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Gräfelfing, , Germany
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Hamburg, , Germany
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Wiesbaden, , Germany
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Mexico City, , Mexico
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Monterrey, , Mexico
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San Pedro Garza García, , Mexico
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Amsterdam, , Netherlands
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Rotterdam, , Netherlands
Countries
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References
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Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17.
Skljarevski V, Zhang S, Chappell AS, Walker DJ, Murray I, Backonja M. Maintenance of effect of duloxetine in patients with chronic low back pain: a 41-week uncontrolled, dose-blinded study. Pain Med. 2010 May;11(5):648-57. doi: 10.1111/j.1526-4637.2010.00836.x. Epub 2010 Apr 13.
Skljarevski V, Desaiah D, Liu-Seifert H, Zhang Q, Chappell AS, Detke MJ, Iyengar S, Atkinson JH, Backonja M. Efficacy and safety of duloxetine in patients with chronic low back pain. Spine (Phila Pa 1976). 2010 Jun 1;35(13):E578-85. doi: 10.1097/BRS.0b013e3181d3cef6.
Other Identifiers
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F1J-MC-HMEN
Identifier Type: -
Identifier Source: secondary_id
10544
Identifier Type: -
Identifier Source: org_study_id