CTRI/2024/01/061844已完成3 期
A Prospective, Randomized, Open-labelled, Multi-centric, Parallel-group, Phase III Study to Assess the Efficacy and Safety of Febuxostat ER Tablet 40/80 mg versus Febuxostat IR Tablet 40/80 mg for treatment of chronic hyperuricemia in conditions where urate depression has already occurred (including a history, or presence of tophus and /or gouty arthritis)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- Evaluation of change in percentage of patients with serum urate concentration < 6mg/dl from baseline
研究概览
简要总结
This is randomized, open-label, comparative, active-controlled, multicentric study comparing the safety and efficacy of Febuxostat ER tablet and Febuxostat IR tablet for 12 weeks in chronic management of hypuricemia in 200 patients with gout. Total 200 patients are proposed to be enrolled. The primary outcome measure will be change in percentage of patients with serum urate concentration < 6mg/dl from baseline [Time frame: Week 2, Week 8, Week12] and secondary outcome measure will be evaluation of Proportion of participants with treatment-emergent adverse events (TEAEs) reported during the study. The anticipated date of enrollment will be Mar 2024. This study is proposed to be conducted in India only
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects of age between 18 to 65 years (both inclusive.)
- •Subjects with history of Gout as defined by ACR criteria.
- •Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Subjects with suspected hypersensitivity to the study medication or any of the ingredients of the formulation.
- •Subjects with serum uric acid levels >15 mg/dl.
- •Subjects with abnormal Liver Function Test (LFT) with values more than 3 times the upper limit of normal.
- •Subjects with abnormal eGFR (<30 mL/min/1.73 m2) will be excluded from the study.
- •Subjects with known case of Type 1 Diabetes will be excluded from the study.
- •Subjects with Type 2 Diabetes Mellitus whose diabetes has not been stable and uncontrolled for the previous three months and with HbA1c value greater than 8% will be excluded from the study.
- •Subjects with history of uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg) within the past 6 months.
- •Subjects with known case of infection with hepatitis B, hepatitis C or HIV.
- •Subjects with known case of symptomatic congestive heart failure, severe aortic stenosis, unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery, sinus node dysfunction and any clinically significant cardiac arrhythmias will be excluded from the study.
- •Subjects with known case of Stroke will be excluded from the study.
- •Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •Females who are not ready to use acceptable contraceptive methods during the course of study.
- •Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •Subjects currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
- •Suspected inability or unwillingness to comply with the study procedures.
结局指标
主要结局
Evaluation of change in percentage of patients with serum urate concentration < 6mg/dl from baseline
时间窗: Time frame baseline, Week 2, Week 8, Week 12
次要结局
- Proportion of participants with treatment-emergent adverse events (TEAEs) reported during the study(Time frame baseline, Week 2, Week 8, Week 12)
研究者
Dr Jigar Modia
Jupiter Hospital and Research Centre
研究点 (9)
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