The Phosphodiesterase 3 Inhibitor Cilostazol as an Adjunct to Conventional Therapy in Patients With Osteoarthritis: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual Analogue scale assessment of pain
研究概览
简要总结
Cilostazol is able to suppress the degradation of type II collagen in human chondrocytes induced by IL-1b. Cilostazol add-on for celecoxib therapy has synergistic anti-arthritic potential by inhibiting proinflammatory cytokine production in synovial fibroblasts through the IL-10/SOCS3 pathways, consequently leading to the inhibition of synovial cell proliferation and overcoming the perpetuation of synovial inflammation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary osteoarthritis Patients recruited were between 30 to 60 years of age, with X-ray confirmed Kellgren-Lawrence grade13 II or III severity primary tibiofemoral OA, according to the American College of Rheumatology criteria.
排除标准
- •Those patients were excluded from the present study who:
- •were of age less than 30 years or more than 60 years
- •presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug
- •were diagnosed to have any inflammatory arthritis, gout or acute trauma of the knee, hip or spine; accompanying OA of the hip of sufficient severity to interfere with the functional assessment of the knee
- •had previous or ongoing treatment with oral SYSDOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics; were having active cardiac lesion or hypertension, were pregnant females and those who were planning their pregnancy during the study
- •were having a known hypersensitivity to the used medications
- •have persistent diarrhoea or laxative use; severe gastrointestinal disorders, severe obesity, severe parenchymal organ disease, or anaemia (haemoglobin< 10.0 g/ dl or haematocrit < 30%).
- •Patients who received oral, intramuscular, intraarticular or soft tissue injections of corticosteroids within last eight weeks before receiving the first dose of the study medication, or had undergone joint lavage and arthroscopic procedures in the previous 6 months, were also excluded.
研究组 & 干预措施
Placebo
Placebo tablet twice daily plus Celecoxib 200mg capsule
干预措施: Placebo (Drug)
Cilostazol
Cilostazol 50 mg twice daily plus Celecoxib 200mg capsule
干预措施: Cilostazol 50 MG (Drug)
结局指标
主要结局
Visual Analogue scale assessment of pain
时间窗: week 12
the change of Visual Analogue Scale (VAS) pain score from baseline to posttreatment. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
次要结局
- WOMAC change(week 12)
- Adverse drug reaction(12 weeks)
- Serum levels of BDNF(12 weeks)
- Serum levels of IL-10(12 WEEKS)
- Serum level Tumor necrosis factor- alpha (TNF-α)(12 weeks)
- the change of Short Form 36 Questionnaire (SF-36) score from baseline to posttreatment(week 12)
- Interleukin 1 beta(12 weeks)
- Serum levels of IL-17(12 weeks)
研究者
Mahmoud Samy Abdallah
Principle Investigator
Sadat City University