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OpenTrials
Completed

NCT Number: NCT05486026

Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee

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.

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Key information

Conditions

Osteo Arthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rizgary and Cmc Hospital

Erbil, 44001, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 40years of age
  • both Genders
  • who will meet the American College of Rheumatology clinical and radiographic criteria for the diagnosis of osteoarthritis of the knee
  • 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

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

Treatment and study plan

Duloxetine 30 MG

Drug

patient in 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. The for 13 weeks

Other names: Cymbalta

Nonsteroidal Antiinflammatory Drug

Drug

patient in this second group will receive NSAID for 3 weeks

Other names: NSAID

Primary outcomes

  1. twenty four hour 24-h average pain scores (short form) in patients with osteoarthritis knee pain

    Time frame: follow-up patients within two months

    it will report in patients' diaries based on the 11-point Likert scale (an ordinal scale with 0 indicating 'no pain', and 10 indicating 'worst pain imaginable')

  2. (WOMAC) WESTERN ONTARIO AND MCMASTER OSTEOARTHITIS INDEX used for evaluation of pain in knee Osteoarthritis

    Time frame: follow-up patients within two months

    which involve three category about rating of pain(5 item) , stiffness(2item), physical function(17 item

Secondary outcomes

  1. The other modality (clinical global improvement)

    Time frame: follow-up patients within two months

    will be used for severity of modality of pain and therapeutic response even side effect of drug

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee: A Randomized Open Labelled Clinical Trial

Acronym: Duloxetine

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 3, 2022
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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