Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee: A Randomized Open Labelled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- twenty four hour 24-h average pain scores (short form) in patients with osteoarthritis knee pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 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
排除标准
- •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 -
研究组 & 干预措施
Duloxetine tablet
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 .
干预措施: Duloxetine 30 MG (Drug)
Duloxetine tablet
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 .
干预措施: Nonsteroidal Antiinflammatory Drug (Drug)
NSAID(non steroidal anti inflammatory)
patient in the second group will receive NSAID(non-steroidal anti inflammatory) drugs for 13 weeks
干预措施: Duloxetine 30 MG (Drug)
NSAID(non steroidal anti inflammatory)
patient in the second group will receive NSAID(non-steroidal anti inflammatory) drugs for 13 weeks
干预措施: Nonsteroidal Antiinflammatory Drug (Drug)
结局指标
主要结局
twenty four hour 24-h average pain scores (short form) in patients with osteoarthritis knee pain
时间窗: 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')
(WOMAC) WESTERN ONTARIO AND MCMASTER OSTEOARTHITIS INDEX used for evaluation of pain in knee Osteoarthritis
时间窗: follow-up patients within two months
which involve three category about rating of pain(5 item) , stiffness(2item), physical function(17 item
次要结局
- The other modality (clinical global improvement)(follow-up patients within two months)
研究者
Aryan Mohamadfatih Jalal
principal investigator
Hawler Medical University