The Effect of Duloxetine on Pain Sensitivity in Patients with Osteoarthritis

Phase 1

• Conditions: MedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-003437-42-DK
• Lead Sponsor: ars Arendt-Nielsen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-30
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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 <150 kg with a body mass index (BMI) between 20-35 kg/m2 inclusive.
3.Patients with osteoarthritic knee based on disease diagnostic criteria as presented in section; Inclusion Disease Criteria.
4.Self-reported pain intensities higher or equal to 5 cm on a 0-10 cm visual analog scale when asked to assess the worst pain within the last 24 hours
5.Have agreed to maintain the same activity level throughout the course of the study.

Patients will meet the following inclusion disease criteria prior to enrolment:
Have been diagnosed with unilateral or bilateral OA of the knee according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence (Altman et al. 1986). The clinical diagnosis of OA will be confirmed by the ACR clinical and radiographic criteria for classification of idiopathic OA of the index knee based upon the following criteria:
1.Knee pain for at least 14 days per month for the last three months before study entry.
2.Osteophytes (with radiographic evidence).
3.At least 1 of the following 3 conditions: Age >50, or morning stiffness <30 minutes, or crepitus.
4.Kellgren and Lawrence grade of I, II or III at the index knee. If the patient has had X-rays of the knee joints within the last year, which can confirm the diagnosis, they may be used. Otherwise, a new posterior-anterior view X-ray of both knees will be conducted by CCBR Aalborg.
5.Worst pain within the last 24-hour must be 5.0cm to 10.0cm (assessed on a 0-10 cm VAS scale anchored at 0cm: no pain and 10cm: worst pain imaginable) prior to enrolment.
6.Discontinued use of all analgesic medications (including over-the-counter [OTC] analgesics/ Non-Steroidal Anti-Inflammatory Drug (NSAID) at least three days prior to randomization (patients are allowed limited use of analgesic medications).
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified