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A Study Comparing Duloxetine Versus Placebo in Patients Taking a Nonsteroidal Anti-inflammatory Drug (NSAID) for Knee Pain Due to Osteoarthritis

NCT ID: NCT01018680

Last Updated: 2012-10-05

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

524 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-04-30

Brief Summary

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The study will test the hypothesis that, in patients with knee pain due to osteoarthritis (OA) who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) but still have significant knee pain, duloxetine 60 to 120 milligrams (mg) daily for 10 weeks will provide additional reduction in pain.

Detailed Description

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Duloxetine has been studied in pain due to osteoarthritis (OA) in 2 previous placebo controlled clinical trials. In clinical practice, when nonsteroidal anti-inflammatory drugs (NSAIDs) are ineffective in reducing pain due to OA, clinicians often add a second agent without discontinuing NSAIDs. In this study, we will investigate whether adding duloxetine to NSAIDs provides additional pain relief and functional improvement in patients with knee pain due to OA.

Conditions

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Osteoarthritis Knee Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Taken by mouth, once daily for 10 weeks

Duloxetine

Group Type EXPERIMENTAL

Duloxetine

Intervention Type DRUG

30 milligrams (mg) taken by mouth, once daily for 1 week, followed by 60 to 120 mg taken by mouth, once daily for 9 weeks.

Interventions

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Duloxetine

30 milligrams (mg) taken by mouth, once daily for 1 week, followed by 60 to 120 mg taken by mouth, once daily for 9 weeks.

Intervention Type DRUG

Placebo

Taken by mouth, once daily for 10 weeks

Intervention Type DRUG

Other Intervention Names

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Cymbalta LY248686

Eligibility Criteria

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Inclusion Criteria

* Present with knee pain due to osteoarthritis (OA) based on OA clinical and radiographic diagnostic criteria.
* Knee Pain for \> 14 days of each month for the 3 months directly preceding study entry.
* Taking nonsteroidal anti-inflammatory drugs (NSAIDs) for knee pain due to OA on most days in the 3 months immediately preceding study entry.

Exclusion Criteria

* History of intolerance or nonresponsiveness to an adequate trial of duloxetine used for any indication, in the opinion of the investigator.
* Previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.
* Have major depressive disorder (MDD) as determined using depression module of the Mini International Neuropsychiatric Interview (MINI).
* Judged clinically by the investigator to be at suicidal risk by examination or using the Columbia Suicide Severity Rating Scale (C-SSRS).
* History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
* Positive urine drug screen for any substance of abuse or excluded medication.
* Opioid dependent in the opinion of the investigator, taking opioids more than 3 days a week, or unwilling to discontinue opioids during the study period.
* Known hypersensitivity to duloxetine or its inactive ingredients.
* History of intolerance or hypersensitivity to NSAIDS, Cyclooxygenase (COX-2) inhibitors, or proton pump inhibitors.
* History of peptic ulcer disease, bleeding disorder, gastrointestinal bleeding, or any abnormal bleeding.
* Baseline hemoglobin measurement of \<11 grams per deciliter (g/dL) for males, or \<10 g/dL for females.
* Serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or any other medical or psychiatric condition that would compromise participation or be likely to lead to hospitalization or a change in medication during the course of the study.
* Uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, uncontrolled or poorly controlled hypertension, or history of seizures.
* Active liver injury (such as hepatitis) or any degree of hepatic insufficiency (Child-Pugh Class C).
* Frequent falls that could result in hospitalization or could compromise response to treatment.
* Confounding painful condition that may interfere with assessment of the index knee.
* Chronic widespread pain affecting all four quadrants of the body, or diagnosis of fibromyalgia.
* Received intra-articular hyaluronate (Synvisc), steroids, joint lavage, or other invasive therapies to the knee in the past 6 months.
* Arthroscopy of the index knee within the past year or joint replacement of the index knee at anytime.
* Diagnosis of inflammatory arthritis (that is, rheumatoid arthritis, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, etc.) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis).
* Prior synovial fluid analysis showing a white blood cell count greater than or equal to 2000 cubic millimeters (mm\^3) that is indicative of a diagnosis other than OA, or have a history of gout or pseudogout.
* Radiographic evidence of end-stage (bone on bone) OA in either knee.
* Knee replacement surgery planned within the next 6 months.
* Nonambulatory or requiring the use of crutches, a walker, or more than 1 cane.
* Body mass index (BMI) \>40.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 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 personal physician.

Tucson, Arizona, United States

Site Status

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Garden Grove, California, United States

Site Status

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Long Beach, California, United States

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San Diego, California, United States

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Spring Valley, California, United States

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Wildomar, California, United States

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Boulder, Colorado, United States

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Cromwell, Connecticut, United States

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DeLand, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

Site Status

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Prairie Village, Kansas, United States

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Lexington, Kentucky, United States

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Mount Sterling, Kentucky, United States

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Pasadena, Maryland, United States

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Wheaton, Maryland, United States

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Fall River, Massachusetts, United States

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Weymouth, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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St Louis, Missouri, United States

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Manlius, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

Site Status

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Beachwood, Ohio, United States

Site Status

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Cincinnati, Ohio, United States

Site Status

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Dayton, Ohio, United States

Site Status

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Duncansville, Pennsylvania, United States

Site Status

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Warwick, Rhode Island, United States

Site Status

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Bellevue, Washington, United States

Site Status

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Spokane, Washington, United States

Site Status

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Ponce, , Puerto Rico

Site Status

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San Germán, , Puerto Rico

Site Status

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San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

Reference Type BACKGROUND
PMID: 3068365 (View on PubMed)

Westfall PH, Krishen A. Optimally weighted, fixed sequence and gatekeeper multiple testing procedures. J Stat Plann Infer. 2001;99(1):25-40.

Reference Type BACKGROUND

Yue L, Wang J, Enomoto H, Fujikoshi S, Alev L, Cheng YY, Skljarevski V. The Clinical Relevance of Pain Severity Changes: Is There Any Difference Between Asian and Caucasian Patients With Osteoarthritis Pain? Pain Pract. 2020 Feb;20(2):129-137. doi: 10.1111/papr.12835. Epub 2019 Nov 20.

Reference Type DERIVED
PMID: 31505082 (View on PubMed)

Risser RC, Hochberg MC, Gaynor PJ, D'Souza DN, Frakes EP. Responsiveness of the Intermittent and Constant Osteoarthritis Pain (ICOAP) scale in a trial of duloxetine for treatment of osteoarthritis knee pain. Osteoarthritis Cartilage. 2013 May;21(5):691-4. doi: 10.1016/j.joca.2013.02.007. Epub 2013 Feb 26.

Reference Type DERIVED
PMID: 23485934 (View on PubMed)

Frakes EP, Risser RC, Ball TD, Hochberg MC, Wohlreich MM. Duloxetine added to oral nonsteroidal anti-inflammatory drugs for treatment of knee pain due to osteoarthritis: results of a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin. 2011 Dec;27(12):2361-72. doi: 10.1185/03007995.2011.633502. Epub 2011 Nov 9.

Reference Type DERIVED
PMID: 22017192 (View on PubMed)

Other Identifiers

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F1J-US-HMGL

Identifier Type: OTHER

Identifier Source: secondary_id

12909

Identifier Type: -

Identifier Source: org_study_id