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Completed

NCT Number: NCT00408876

Duloxetine Versus Placebo in Chronic Low Back Pain

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.

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Key information

Conditions

Back Pain Without Radiation Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Duloxetine

Drug

Other names: LY248686, Cymbalta

Placebo

Drug

Primary outcomes

  1. Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores

    Time frame: Baseline, Week 1

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).

  2. Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores

    Time frame: Baseline, Week 2

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 2), with scores ranging from 0 (no pain) to 10 (worst possible pain).

  3. Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores

    Time frame: Baseline, Week 3

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 3), with scores ranging from 0 (no pain) to 10 (worst possible pain).

  4. Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores

    Time frame: Baseline, Week 4

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 4), with scores ranging from 0 (no pain) to 10 (worst possible pain).

  5. Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores

    Time frame: Baseline, Week 5

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 5), with scores ranging from 0 (no pain) to 10 (worst possible pain).

  6. Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores

    Time frame: Baseline, Week 6

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 6), with scores ranging from 0 (no pain) to 10 (worst possible pain).

  7. Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores

    Time frame: Baseline, Week 7

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 7), with scores ranging from 0 (no pain) to 10 (worst possible pain).

  8. Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores

    Time frame: Baseline, Week 8

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 8), with scores ranging from 0 (no pain) to 10 (worst possible pain).

  9. Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores

    Time frame: Baseline, Week 9

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).

  10. Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores

    Time frame: Baseline, Week 10

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 10), with scores ranging from 0 (no pain) to 10 (worst possible pain).

  11. Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores

    Time frame: Baseline, Week 11

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 11), with scores ranging from 0 (no pain) to 10 (worst possible pain).

  12. Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores

    Time frame: Baseline, Week 12

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 12), with scores ranging from 0 (no pain) to 10 (worst possible pain).

  13. Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores

    Time frame: Baseline, Week 13

    24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 13), with scores ranging from 0 (no pain) to 10 (worst possible pain).

Secondary outcomes

  1. Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint

    Time frame: Week 13

    A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from

    1 (very much better) to 7 (very much worse).

  2. Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score

    Time frame: Baseline, Week 13

    Roland-Morris questionnaire was completed by the patient and measured the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient was instructed to put a mark next to each appropriate statement. The number of statements marked was added up by the clinician and a total score was given. The total score ranges from 0 (no disability) to 24 (severe disability).

  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

    The 11-point Likert scale was used for assessment of 24-hour night pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).

  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

    The 11-point Likert scale was used for assessment of 24-hour worst pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).

  5. Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity

    Time frame: Baseline, Week 13

    Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

  6. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score

    Time frame: Baseline, Week 13

    A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

  7. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score

    Time frame: Baseline, Week 13

    A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

  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

    A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

  10. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity

    Time frame: Baseline, Week 13

    A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

  11. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood

    Time frame: Baseline, Week 13

    A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

  12. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability

    Time frame: Baseline, Week 13

    A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

  13. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work

    Time frame: Baseline, Week 13

    A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

  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

    A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

  15. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep

    Time frame: Baseline, Week 13

    A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

  16. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life

    Time frame: Baseline, Week 13

    A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

  17. Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference

    Time frame: Baseline, Week 13

    A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).

  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

    Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.

  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

    The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).

  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

    The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).

  23. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain

    Time frame: Baseline, Week 13

    The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Bodily pain scores range from 2-11 (higher scores indicate better health status).

  24. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health

    Time frame: Baseline, Week 13

    The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). General health scores range from 5-25(higher scores indicate better health status).

  25. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health

    Time frame: Baseline, Week 13

    The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Mental health scores range from 5-30 (higher scores indicate better health status).

  26. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning

    Time frame: Baseline, Week 13

    The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Physical functioning scores range from 10-30 (higher scores indicate better health status).

  27. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional

    Time frame: Baseline, Week 13

    The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Role-emotional scores range from 3-6 (higher scores indicate better health status).

  28. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical

    Time frame: Baseline, Week 13

    The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Role-physical scores range from 4-8 (higher scores indicate better health status).

  29. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning

    Time frame: Baseline, Week 13

    The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Social functioning scores range from 2-10 (higher scores indicate better health status).

  30. Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality

    Time frame: Baseline, Week 13

    The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). Vitality scores range from 4-24 (higher scores indicate better health status).

  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

    The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient.

  32. Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score

    Time frame: Baseline, Week 13

    A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

  33. Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale

    Time frame: Baseline, Week 13

    A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Protocol F1J-MC-HMEO Duloxetine Versus Placebo in the Treatment of Chronic Low Back Pain

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 7, 2006
Registry last updated
Dec 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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