Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee

Hawler Medical University

Status and phase: Completed; Phase 2

Conditions: Osteo Arthritis Knee

Treatments: Drug: Nonsteroidal Antiinflammatory Drug; Drug: Duloxetine 30 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05486026

Efficacy of Duloxetine

Details and patient eligibility

About

Osteoarthritis (OA) is the most common degenerative joint disease, affecting more than 25% of the population . Knee OA is an insidious disease related to structural changes in the joint over many years. Progressive articular damage results in a loss of the extracellular matrix of cartilage in addition to changes in subchondral bone.

Duloxetine, a selective serotonin, and norepinephrine reuptake inhibitor, it seems to be effective in treating neuropathic and chronic pain conditions.

Full description

This will be a 13-week A randomized open labelled clinical trail in Iraqi Kurdistan Region, that will be designed to assess the efficacy of duloxetine tablet compared with other group (Nonsteroidal anti-inflammatory) drug on the reduction of pain caused by osteoarthritis of the knee.

Patients will be divided into two groups, first group (case) will receive duloxetine tablet 30mg for two weeks then titrated up to duloxetine 30mg BID. Patients will be instructed to take the medication with meals. Patients will be observed at visits (0) baseline then at second visits at 13 weeks then will be compared to control group that will receive NSAID (nonsteroidal anti-inflammatory drug) at baseline (0) visit then 2nd visits at 13 weeks.

Enrollment: 200 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. > 40years of age
2. both Genders
3. who will meet the American College of Rheumatology clinical and radiographic criteria for the diagnosis of osteoarthritis of the knee
4. with pain for ≥14days of each separate month for 3months before study entry, with a mean score ≥4 on the 24-h average pain score (0-10) using the average of daily ratings

Exclusion criteria

1. if they have diagnosed with inflammatory arthritis or an autoimmune disease
2. if they received invasive therapy in last 3 months (knee arthroscopy) or knee replacement at any time
3. patients with psychiatric disorders
4. Hypertension
5. Heart disease
6. patients on antipsychotics or anti-depressant -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Duloxetine tablet

Active Comparator group

Description:

Patient in the first group (case) will receive duloxetine tablet 30mg for two weeks then titrated up to duloxetine 30mg BID. Patients will be instructed to take the medication with meals for 13 weeks .

Treatment:

Drug: Nonsteroidal Antiinflammatory Drug

Drug: Duloxetine 30 MG

NSAID(non steroidal anti inflammatory)

Active Comparator group

Description:

patient in the second group will receive NSAID(non-steroidal anti inflammatory) drugs for 13 weeks

Treatment:

Drug: Nonsteroidal Antiinflammatory Drug

Drug: Duloxetine 30 MG