MedDRA version: 21.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Duloxetine
Product Name: Duloxetin Lilly 30 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DULOXETINE
CAS Number: 116539-59-4
Concentration unit: mg milligram(s)
Concentration
Sponsors
Lars Arendt-Nielsen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will meet the following inclusion criteria prior to enrolment: 1.Provide written informed consent and abide by the study restrictions. 2.Males and females between 40 and 75 years of age and body weight >40 kg and 50, or morning stiffness =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria are not eligible for participation in the study: 1.Have secondary causes of arthritis of the knee including septic arthritis, inflammatory joint disease, articular fracture, major dysplasia or congenital abnormality, acromegaly, hemochromatosis, Wilson's disease, and primary osteochondromatosis. 2.Have had lower extremity surgery (including arthroscopy of the index knee) within 3 months prior to Visit 1 or have surgery planned of the index knee at any time. 3.Have had significant prior injury to the index knee within 12 months prior to Visit 1. 4.Use of lower extremity assistive devices other than a cane or knee brace (use of a 'shoe lift' is permitted). Are non-ambulatory or require the use of crutches or a walker. Use of a cane in the hand opposite the index knee is acceptable. 5.Has had a prior synovial fluid analysis showing a White Blood Cell (WBC) =2000mm3 that is indicative of a diagnosis other than OA at the index knee. 6.Have a confounding painful condition that may interfere with assessment of the index knee. (Knee pain should be the predominant pain. Mild OA of the hands is allowed, for instance). 7.Have any other musculoskeletal or arthritic condition that may affect the interpretation of the clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study (i.e., currently symptomatic fractures or any concurrent rheumatic diseases such as but not limited to fibromyalgia, rheumatoid arthritis, gout, pseudo-gout or Paget's disease and Reiter's syndrome are excluded). 8.Have used corticosteroids prior to baseline: a. Intra-articular injection of steroids to the index knee or into any other site than the index knee within the previous three months. b. Intra-muscular corticosteroid injections within the previous three months. c. Oral corticosteroids within the previous one month. 9.Have initiated or have changed to an established physiotherapy program within two weeks prior to Visit 2 or during the study period. An established physiotherapy program may be continued throughout the study period if unchanged in frequency and intensity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess which experimental pain mechanisms are modulated by Duloxetine compared to placebo in patients with knee osteoarthritis. ;Secondary Objective: The secondary objectives are to assess the effect by Duloxetine compared to placebo on a different pain scores in patients with knee osteoarthritis. ;Primary end point(s): Modulation of pain mechanisms;Timepoint(s) of evaluation of this end point: Change in pain mechanims comparing baseline and end of study parameters for duloxetine and placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Modulation of pain intensities. ;Timepoint(s) of evaluation of this end point: Change in pain scores comparing baseline and end of study parameters for duloxetine and placebo. | — |
Countries
Denmark
Contacts
Public ContactProfessor
Lars Arendt-Nielsen
Outcome results
None listed