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Completed

NCT Number: NCT00433290

Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.

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Key information

Conditions

Osteoarthritis Knee Pain

Age range

40 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 physician., Athens, Greece

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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 or female outpatients with osteoarthritis knee pain.

Exclusion criteria

  • Serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
  • Previous exposure to duloxetine.

Treatment and study plan

Duloxetine

Drug

duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders

Other names: LY248686, Cymbalta

Placebo

Drug

placebo every day (QD), by mouth (PO) for 13 weeks

Primary outcomes

  1. Change in Brief Pain Inventory (BPI) 24-hour Average Rating

    Time frame: Baseline, Week 4, Week 7, Week 13

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

Secondary outcomes

  1. Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)

    Time frame: 13 Weeks

    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 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale

    Time frame: Baseline and 13 Weeks

    The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme).

  3. Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale

    Time frame: Baseline and 13 Weeks

    The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme).

  4. Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale

    Time frame: Baseline and 13 Weeks

    The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme).

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

    Time frame: Baseline and 13 Weeks

    This assesses the weekly mean of the average pain and worst pain experienced over the last 24-hours. This is an ordinal scale with scores for each subscale (average pain and worst pain) ranging from 0 (no pain) to 10 (worst possible pain). Change = endpoint minus baseline.

  6. Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)

    Time frame: Baseline and 13 Weeks

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

  7. Number of Participants Who Responded to Treatment at 13 Week Endpoint

    Time frame: 13 Weeks

    Response to treatment was defined as a ≥ 30% reduction from baseline to endpoint in Brief Pain Inventory (BPI) average pain score. The BPI measures the severity of pain based on the average 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. Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores

    Time frame: Baseline and 13 Weeks

    MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores:general health=5-25, physical functioning=10-30, Role-physical=4-8, Role-emotional=3-6, social functioning=2-10, bodily pain=2-11, vitality=4-24, mental health=5-30.

  9. Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)

    Time frame: Baseline and 13 Weeks

    The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.

  10. Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)

    Time frame: Baseline and 13 Weeks

    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.

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

    Time frame: Baseline and 13 Weeks

    A 14-item questionnaire with 2 subscales: anxiety (7 items) and depression (7 items). Each item is rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety subscale. Scores of 11 or more are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'

  12. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score

    Time frame: Baseline and 13 Weeks

    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).

  13. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score

    Time frame: Baseline and 13 Weeks

    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).

  14. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score

    Time frame: Baseline and 13 Weeks

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

  15. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score

    Time frame: Baseline and 13 Weeks

    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).

  16. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity

    Time frame: Baseline and 13 Weeks

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

  17. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood

    Time frame: Baseline and 13 Weeks

    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).

  18. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability

    Time frame: Baseline and 13 Weeks

    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).

  19. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work

    Time frame: Baseline and 13 Weeks

    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).

  20. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People

    Time frame: Baseline and 13 Weeks

    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).

  21. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep

    Time frame: Baseline and 13 Weeks

    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).

  22. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life

    Time frame: Baseline and 13 Weeks

    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).

  23. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference

    Time frame: Baseline and 13 Weeks

    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).

  24. Adverse Events Reported as Reason for Discontinuation

    Time frame: over 13 weeks

  25. Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes

    Time frame: Baseline and 13 Weeks

  26. Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride

    Time frame: Baseline and 13 Week Endpoint

  27. Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate

    Time frame: Baseline and 13 Weeks

  28. Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure

    Time frame: Baseline and 13 Weeks

  29. Change From Baseline to 13 Week Endpoint in Vital Signs - Weight

    Time frame: Baseline and 13 Weeks

  30. Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders

    Time frame: Baseline and 13 Weeks

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

    Non-Responders were defined as patients with a <30% reduction from baseline to visit 4 (7 weeks) in Brief Pain Inventory (BPI) average pain score.

  31. Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint

    Time frame: 13 Weeks

    Response was defined as a >=30% reduction from baseline to endpoint in Brief Pain Inventory average pain score. Nonresponders were defined as participants with a <30% reduction from baseline to Visit 4 (7 Weeks) in Brief Pain Inventory average pain score.

  32. Adverse Events Reported as Reason for Discontinuation in Nonresponders

    Time frame: over 13 Weeks

    Nonresponders were defined as participants with a <30% reduction from baseline to Visit 7 (7 weeks) in Brief Pain Inventory average pain score.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Protocol F1J-MC-HMFG Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 9, 2007
Registry last updated
Sep 2, 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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