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Duloxetine Versus Placebo in Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT00408876
Recruitment Status : Completed
First Posted : December 7, 2006
Results First Posted : December 29, 2009
Last Update Posted : December 29, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition--Whether duloxetine once daily can help patients with Chronic Low Back Pain.

Condition or disease Intervention/treatment Phase
Back Pain Without Radiation Drug: Duloxetine Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Protocol F1J-MC-HMEO Duloxetine Versus Placebo in the Treatment of Chronic Low Back Pain
Study Start Date : December 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Duloxetine 20 mg
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
Drug: Duloxetine
Other Names:
  • LY248686
  • Cymbalta

Experimental: Duloxetine 60 mg
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
Drug: Duloxetine
Other Names:
  • LY248686
  • Cymbalta

Experimental: Duloxetine 120 mg
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
Drug: Duloxetine
Other Names:
  • LY248686
  • Cymbalta

Placebo Comparator: Placebo
placebo once a day (QD), by mouth (PO) for 13 weeks
Drug: Placebo



Primary Outcome Measures :
  1. Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores [ Time Frame: Baseline, Week 1 ]
  2. Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 2 ]
  3. Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 3 ]
  4. Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 4 ]
  5. Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 5 ]
  6. Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 6 ]
  7. Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 7 ]
  8. Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 8 ]
  9. Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 9 ]
  10. Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 10 ]
  11. Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 11 ]
  12. Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 12 ]
  13. Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores [ Time Frame: Baseline, Week 13 ]

Secondary Outcome Measures :
  1. Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint [ Time Frame: Week 13 ]
  2. Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score [ Time Frame: Baseline, Week 13 ]
  3. Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score [ Time Frame: Baseline, Week 13 ]
  4. Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score [ Time Frame: Baseline, Week 13 ]
  5. Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity [ Time Frame: Baseline, Week 13 ]
  6. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score [ Time Frame: Baseline, Week 13 ]
  7. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score [ Time Frame: Baseline, Week 13 ]
  8. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score [ Time Frame: Baseline, Week 13 ]
  9. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score [ Time Frame: Baseline, Week 13 ]
  10. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity [ Time Frame: Baseline, Week 13 ]
  11. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood [ Time Frame: Baseline, Week 13 ]
  12. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability [ Time Frame: Baseline, Week 13 ]
  13. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work [ Time Frame: Baseline, Week 13 ]
  14. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People [ Time Frame: Baseline, Week 13 ]
  15. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep [ Time Frame: Baseline, Week 13 ]
  16. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life [ Time Frame: Baseline, Week 13 ]
  17. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference [ Time Frame: Baseline, Week 13 ]
  18. Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward [ Time Frame: Baseline to Week 13 ]
  19. Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward [ Time Frame: Baseline to Week 13 ]
  20. Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale [ Time Frame: Baseline, Week 13 ]
  21. Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS) [ Time Frame: Baseline, Week 13 ]
  22. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS) [ Time Frame: Baseline, Week 13 ]
  23. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain [ Time Frame: Baseline, Week 13 ]
  24. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health [ Time Frame: Baseline, Week 13 ]
  25. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health [ Time Frame: Baseline, Week 13 ]
  26. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning [ Time Frame: Baseline, Week 13 ]
  27. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional [ Time Frame: Baseline, Week 13 ]
  28. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical [ Time Frame: Baseline, Week 13 ]
  29. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning [ Time Frame: Baseline, Week 13 ]
  30. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality [ Time Frame: Baseline, Week 13 ]
  31. Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score [ Time Frame: Baseline, Week 13 ]
  32. Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score [ Time Frame: Baseline, Week 13 ]
  33. Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale [ Time Frame: Baseline, Week 13 ]
  34. Adverse Events Reported as Reason for Discontinuation [ Time Frame: Baseline to Week 13 ]
  35. Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase [ Time Frame: Baseline, Week 13 ]
  36. Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase [ Time Frame: Baseline, Week 13 ]
  37. Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3 [ Time Frame: Baseline, Week 13 ]
  38. Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct [ Time Frame: Baseline, Week 13 ]
  39. Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total [ Time Frame: Baseline, Week 13 ]
  40. Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride [ Time Frame: Baseline, Week 13 ]
  41. Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol [ Time Frame: Baseline, Week 13 ]
  42. Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine [ Time Frame: Baseline, Week 13 ]
  43. Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium [ Time Frame: Baseline, Week 13 ]
  44. Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid [ Time Frame: Baseline, Week 13 ]
  45. Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate [ Time Frame: Baseline, Week 13 ]
  46. Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure [ Time Frame: Baseline, Week 13 ]
  47. Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure [ Time Frame: Baseline, Week 13 ]
  48. Change From Baseline to Week 13 Endpoint in Vital Signs - Weight [ Time Frame: Baseline, Week 13 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: - Male/Female outpatients 18 years of age with chronic low back pain. Exclusion Criteria: - You have a serious or unstable disease of the heart or blood vessels, liver, kidney, lungs, or blood-related illness, problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions, or 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 major depressive disorder. - Require daily narcotics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408876


Locations
United States, Florida
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 ph
Fort Myers, Florida, United States, 33912
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 ph
Orlando, Florida, United States, 32806
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 ph
South Miami, Florida, United States, 33143
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 ph
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00408876     History of Changes
Other Study ID Numbers: 10545
F1J-MC-HMEO
First Posted: December 7, 2006    Key Record Dates
Results First Posted: December 29, 2009
Last Update Posted: December 29, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents