Duloxetine 60 mg once daily versus Placebo in the Treatment of Patients with Osteoarthritis Knee Pain - HMGP
- Conditions
- Osteoarthritis Knee PainMedDRA version: 9.1Level: LLTClassification code 10023476Term: Knee osteoarthritis
- Registration Number
- EUCTR2009-010008-27-GR
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 422
[1] Are male or female outpatients at least 40 years of age.
[2] Female patients: women of child-bearing potential who test negative
for pregnancy at the time of enrollment based on a serum pregnancy
test and agree to use a reliable method of birth control during the study
and for 1 month following the last dose of study drug; OR women not
of child-bearing potential due to surgical sterilization (hysterectomy or
bilateral oophorectomy or tubal ligation) or menopause.
[3] Meet the American College of Rheumatology (ACR) clinical and
radiographic criteria for the diagnosis of OA of the knee
[4] Have OA knee pain for =14 days of each month for 3 months prior to
study entry.
[5] Have a rating of greater than or equal to 4 on the BPI average pain
item (Question 3 of the BPI modified short form) at both Visit 1 and
Visit 2.
[6] Have an education level and a degree of understanding such that the
patient can communicate intelligibly with the site study personnel.
[7] Are judged to be reliable and agree to keep all appointments for clinic
visits, tests, and procedures required by the protocol.
[8] Have agreed to maintain the same activity level throughout the course
of the study. Continuation of long-term, regular, non-pharmacological
treatments such as physical therapy or relaxation therapy is allowed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
[9] Are investigator site personnel directly affiliated with this study and/or their immediate families
[10] Are employed by Lilly
[11] Are currently enrolled in, or discontinued within the last 30 days from, a clinical study involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
[12] Have previously completed or withdrawn from this study or any other
study investigating duloxetine
[13] Have had any previous exposure to duloxetine
[14] Have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
[15] Have MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, as assessed by the Mini International Neuropsychiatric Interview or diagnosed within the past year
[16] Have a history of substance abuse or dependence within the past year
[17] Are taking any excluded medications that cannot be discontinued at Visit 1
[18] Have current or pending disability compensation or litigation issues that may compromise response to treatment, in the opinion of the investigator
[19] Have had treatment with a MAOI within 14 days of randomization or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug.
[20] Have a positive urine drug screen for any substance of abuse or
excluded medication.
[21] Are pregnant or breast-feeding
[22] Have 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
[23] Have a history of recurrent seizures other than febrile seizures
[24] Are judged by the investigator to be at suicidal risk
[25] Have uncontrolled narrow-angle glaucoma
[26] Have acute liver injury or severe cirrhosis
[27] Have known hypersensitivity to duloxetine or any of the inactive ingredients or patients with frequent or severe allergic reactions to multiple medications
[28] Have frequent falls that could result in hospitalization or could compromise response to treatment
[29] Have a confounding painful condition that may interfere with assessment of the index joint, that is, knee.
[30] Have a diagnosis of inflammatory arthritis or an autoimmune disorder
[31] Have received intrarticular hyaluronate or steroids, joint lavage, or other invasive therapies to the knee in the past 3 months
[32] Have had knee arthroscopy of the index knee within the past year or
joint replacement of the index knee at anytime
[33] Have surgery planned during the study for the index joint
[34] Have had a prior synovial fluid analysis showing a white blood cell
(WBC) = 2000 mm3 that is indicative of a diagnosis other than OA.
[35] Are non-ambulatory or require the use of crutches or a walker.
[36] Have a BMI over 40.
[37] Use of acupuncture, chiropractic maneuvers, TENS
[38] Patients who are anticipated by the investigator to require use of analgesic agents including but not limited to NSAIDs, acetaminophen/paracetamol, and opioids, or other excluded medication for the duration of the study.
[39] Are unwilling or unable to comply with the data collection method used to record their patient rated outcome data.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method