Duloxetine Versus Placebo for Osteoarthritis Knee Pain

Eli Lilly and Company231 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

231

Conditions

Osteoarthritis Knee Pain

Interventions

DuloxetineDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female outpatients with osteoarthritis knee pain. Exclusion Criteria: * 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. * Acute liver injury (such as hepatitis) or severe cirrhosis. * Previous exposure to duloxetine. * Body Mass Index (BMI) over 40. * Major depressive disorder. * Daily use of narcotics.

Locations (27)

Outcomes

Primary Outcomes

Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary

This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain).

Time frame: Over 13 Weeks

Secondary Outcomes

Patient Global Impression of Improvement at 13 Week Endpoint

A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).

Time frame: 13 Weeks

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

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).

Time frame: Baseline and 13 Weeks

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

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).

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale

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).

Data from ClinicalTrials.gov

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Chandler, Arizona, United States

Beverly Hills, California, United States

Northridge, California, United States

Walnut Creek, California, United States

DeLand, Florida, United States

Fort Myers, Florida, United States

South Miami, Florida, United States

Stuart, Florida, United States

Chicago, Illinois, United States

Morton Grove, Illinois, United States

...and 17 more locations

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score

The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme).

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score

This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.

Time frame: Baseline and 13 Weeks

Weekly Change From Baseline in the 24-Hour Worst Pain Score

This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.

Time frame: Over 13 Weeks

Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase

This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). This value is the change from baseline in the weekly mean of the 24-hour average pain score on the scale.

Time frame: Baseline and 13 Weeks

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

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.

Time frame: Baseline and 13 Weeks

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

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).

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score

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).

Time frame: Baseline and 13 Weeks

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

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).

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score

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).

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity

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).

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood

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).

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability

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).

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work

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).

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People

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).

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep

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).

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life

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).

Time frame: Baseline and 13 Weeks

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

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).

Time frame: Baseline and 13 Weeks

Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings

Number of participants who experienced a response to treatment, which was defined as having a \>=30% reduction of the weekly mean in 24-hour average pain severity ratings. This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain).

Time frame: Over 13 Weeks

Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase

Number of participants who experienced a response to treatment, which was defined as having a \>=30% reduction of the weekly mean in 24-hour average pain severity ratings. Response to treatment over the last 6 weeks of the trial (after patients were re-randomized) were compared to baseline measures.

Time frame: Over 13 Weeks

Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary

A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) has been constructed based on the 8 SF-36 domains.

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary

A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains.

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score

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.

Time frame: Baseline and 13 Weeks

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

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.

Time frame: Baseline and 13 Weeks

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

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.'

Time frame: Baseline and 13 Weeks

Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase

Change from baseline to endpoint in alkaline phosphatase using central laboratory reference ranges.

Time frame: Baseline and 13 Weeks

Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid

Change from baseline to endpoint in uric acid using central laboratory reference ranges.

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate

Pulse rate (heart rate) measured in the sitting position.

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic

Diastolic blood pressure measured in the sitting position.

Time frame: Baseline and 13 Weeks

Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic

Systolic blood pressure measured in the sitting position.

Time frame: Baseline and 13 Weeks

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

Time frame: Baseline and 13 Weeks