A Randomized, Open Label, Active-Controlled, Multicentre, Prospective, Comparative, Phase III Clinical study to assess the Efficacy, Safety and Tolerability of Oxaceprol SR Tablets 600 mg Once daily with Oxaceprol Capsules 200 mg Three times daily for the treatment of patients with Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- Improvement in Western Ontario and McMasters (WOMAC) individual osteoarthritis (OA) indices and Composite Index (for pain, stiffness and physical function).
研究概览
简要总结
This is a randomized, open label, active-controlled, multicentre, prospective, comparative, phase III clinical study. Study will enroll 200 patients with osteoarthritis from the different centers in India.
Patients will be recruited after providing written informed consent. After screening, patients will be randomized (meeting all inclusion & none of the exclusion criteria) in 1:1 ratio to receive either Oxaceprol SR Tablets 600 mg once daily or Oxaceprol Capsules 200 mg three times daily for six weeks. The primary efficacy endpoint of the study is improvement in Western Ontario and McMasters (WOMAC) individual osteoarthritis (OA) indices and Composite Index (for pain, stiffness and physical function) & improvement in Visual Analog Scale (VAS) at the end of treatment. Secondary efficacy endpoint include improvement in Subject’s and Physician’s Global Assessment of Osteoarthritis.During the study, there will be 5 study visits for efficacy, safety and tolerability assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects, aged ≥30 years to ≤65 years at the time of informed consent.
- •2.Clinically diagnosed with sign and symptoms of Osteoarthritis of Knee.
- •3.Patient having grade 1-3 in Osteoarthritis condition according to Kellgren and Lawrence grading scale.
- •4.Knee pain present for at least one month in the preceding three months with at least one of the following: morning stiffness less than 30 min or knee crepitus.
- •5.Knee pain on movement of intensity at least 40 mm or above on a 100 mm VAS (Visual Analogue Score) scale.
排除标准
- •1.Pregnant or nursing women.
- •2.Patients having inflammatory arthritis, gout, pseudogout, Paget’s disease or any chronic pain syndrome that may interfere with assessment of the knee.
- •3.Prior intra-articular injection of hyaluronic acid / steroid / joint lavage in the study knee any time in the past three months.
- •4.Knee injury or diagnostic arthroscopy of signal knee within 6 months preceding enrolment or knee surgery (including arthroscopic surgery requiring an incision of the internal joint components) in the study knee, at any time.
- •5.Severe and advanced OA disease, defined as joint space width 2 mm or deformed joint, or disease necessitating knee surgery in the current year.
- •6.Subject unlikely to provide informed consent, follow the study protocol or any other criteria, which in the opinion of the investigator, is not conducive to enrolment of a particular subject into the trial.
- •7.History of bleeding tendencies, cirrhosis and oesophageal varices.
- •8.Hypersensitive to Oxaceprol.
- •9.History of hypersensitivity or allergy to NSAIDs, other COX-2 inhibitors and/or sulphonamides.
- •10.Pre-existing asthma.
- •11.Patients who would require concomitant therapy with drugs e.g. low dose aspirin, warfarin, anti-epileptics, fluconazole (inhibitor of CYP 2C9/3A4), ketoconazole (a known inhibitor of CYP 3A4) etc.
- •13.Conditions predisposing to gastrointestinal dysfunction (e.g., history of peptic ulcer, upper gastrointestinal disease, ulcerative colitis; smoking; advancing age; concurrent corticosteroids; alcohol abuse; etc.).
- •14.Patients with severe cardiac, hepatic, renal, or cerebrovascular disease, malignancy, chronic uncontrolled systemic diseases e.g., diabetes, hypertension, collagen disorders, etc.
- •or any other serious medical illness.
结局指标
主要结局
Improvement in Western Ontario and McMasters (WOMAC) individual osteoarthritis (OA) indices and Composite Index (for pain, stiffness and physical function).
时间窗: At visit 1, visit 2, visit 3, visit 4 and visit 5
Improvement in Visual Analog Scale (VAS).
时间窗: At visit 1, visit 2, visit 3, visit 4 and visit 5
次要结局
- Improvement in Subject’s and Physician’s Global Assessment of Osteoarthritis(At visit 1, visit 3, visit 4 and visit 5)