CTRI/2009/091/000745已完成3 期
A Phase IIb/III, Multi-Center, Randomized, Parallel Group, Controlled Study to Evaluate the Efficacy and Safety of 750 mg and 1000 mg of LLL-3348 of Lupin Limited in Moderate to Severe Chronic Stable Plaque Type of Psoriasis
upin Research Park, 46 A/47A, Nande Village, Mulshi Taluka Pune-411042Maharashtra (India)0 个研究点目标入组 330 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 330
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. Patients with moderate to severe Chronic Stable Plaque Psoriasis with PASI score of ≥10.
- •2. Either males or females aged 18 to 60 years.
- •3. Patients who have not used for 2 weeks the anti-psoriatic therapy including ultraviolet D phototherapy, topical corticosteroids, vitamin A or D analogues or anthralin and who have not used for 4 weeks the anti-psoriatic therapy including PUVA, or any systemic anti-psoriatic treatment (systemic corticosteroids, immunosuppresants or any other systemic therapy including those on Methotrexate 2 months prior to screening).
- •4. Patients willing to sign Informed Consent Form.
排除标准
- •1. Patients who have been treated with Methotrexate within 2 months prior to screening.
- •2. Pregnant women or nursing mothers
- •3. Women of child bearing potential & all men who are not willing to use reliable & effective contraceptive measures during the course of the study & at least 3 months after the last visit.
- •4. Patients with guttate, erythrodermic, or pustular psoriasis and any other active skin conditions that would interfere with evaluations.
- •5. Patients with a co-existing disease for which they have to take a concomitant medication with anti-psoriasis activity, such as: systemic corticosteroids, immuno-suppressants etc.
- •6. Patient with active uncontrolled infectious disease.
- •7. Patients with any serious disease that would interfere with the compliance to study protocol and proper completion of the trial
- •8. Patient with severe anemia, leucopenia or thrombocytopenia or any other clinically significant blood disorders
- •9. Patients with hepatitis/ fibrosis, cirrhosis, or any other active hepatic disorders or any abnormal kidney functions
- •10. Patients with uncontrolled diabetes & hypertension
- •11. Patients with any screening laboratory values that deviate from upper or lower limits of the reference range, except for clinically insignificant deviations as determined by the Investigator
- •12. Serum SGOT and SGPT > 3 X , Alkaline Phosphatase > 1.5 X , Creatinine > 1.5 X and Total bilirubin >1.5 X the Upper Limit of Normal (ULN) of the reference range at the screening assessment
- •13. Patient receiving medicines with antifolate properties (e.g., co-trimoxazole)
- •14. Patients with major psychiatric disorder that is not well controlled with treatment
- •15. Patients with history of acute myocardial infarction or stroke within 6 months of signing informed consent
- •16. Patients with Alcohol or drug dependence
- •17. Patients who have received any other investigational drug within 4 weeks prior to screening.
- •18. Patients who are doubtful to comply with study procedures for social or psychological reason
- •19. Patients with clinically significant cardiovascular, haemopoetic, endocr
研究者
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