CTRI/2019/04/018689已完成3 期
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
- 219
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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, Pagetâ??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.
- •12.Immuno compromised states and patients with systemic infections.
- •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.
研究者
相似试验
已完成
3 期
A Clinical Trial to study the effect of Ulipristal Acetate Tablets 30 mg in Women requiring emergency contraceptioCTRI/2019/09/021343Synokem Pharmaceuticals Ltd102
已完成
不适用
A Randomized, Open Label, Active-controlled, Multiple Dosing and Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of YH4808 after Postprandial Oral Administration in Healthy VolunteersKCT0000695Yuhan20
进行中（未招募）
1 期
A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered with Daclatasvir in Adults with Chronic Hepatitis C Virus Genotype 3 Infection (ENDURANCE-3)Chronic HCV Genotype 3 InfectionMedDRA version: 18.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2015-002272-24-SEAbbVie Deutschland GmbH & Co. KG345
进行中（未招募）
1 期
A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered with Daclatasvir in Adults with Chronic Hepatitis C Virus Genotype 3 Infection (ENDURANCE-3)EUCTR2015-002272-24-GBAbbVie Deutschland GmbH & Co. KG506
进行中（未招募）
1 期
A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered with Daclatasvir in Adults with Chronic Hepatitis C Virus Genotype 3 Infection (ENDURANCE-3)Chronic HCV Genotype 3 InfectionMedDRA version: 18.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2015-002272-24-DEAbbVie Deutschland GmbH & Co. KG460