CTRI/2015/10/006262已完成3 期
A phase III randomized, double blind, multicenter, comparative, prospective clinical trial to evaluate the efficacy and safety of Bepotastine tablet vs. Fexofenadine tablet in patients of Allergic Rhinitis. - Bepotastine tablet
upin Limited India0 个研究点目标入组 240 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
- 240
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
- •2.Patient with symptoms of allergic rhinitis characterized by nasal pruritus, sneezing, rhinorrhea, and nasal congestion.
- •3.Patients with a Total Nasal Symptom Score (TNSS; the sum of all the 4 individual nasal symptom scores) of 6 or greater and/or a Total Ocular Symptom Score (TOSS; the sum of all the 3 individual ocular symptom scores) of 4 or greater and rhinitis symptoms.
- •4.Except Allergic Rhinitis disorders patient is judged to be in general good health based on medical history, physical examination and laboratory tests as assessed by the Investigator.
- •5.Written informed consent signed by patient and willing to comply with the study procedure.
- •6.Female patient of childbearing potential definitely using effective contraception during the study and willing to undergo pregnancy test.
排除标准
- •1.Pregnant and lactating female patient.
- •2.Patient with known history of hypersensitivity to Bepotastine tablet or Fexofenadine tablet or its components.
- •3.Patients receiving oral or topical H1 receptor antagonists within the last 48 hrs of enrollment.
- •4.Patients receiving antiallergic or antipruritic agents, antihistamines, corticosteroids, NSAIDs, tranquillizers and cold remedies.
- •5.Serum Creatinine & BUN levels above the normal range of 0.6 to1.0 mg/dL & 7 to 18 mg/dL respectively.
- •6.Serum transaminases (SGOT & SGPT) levels more than 3 times the upper limit of normal (ULN: SGOT- 37 U/L, SGPT- 65 U/L) and total serum bilirubin level more than 1.5 times the upper limit of normal (ULN: 1.0 mg/dL).
- •7.Patients with upper respiratory tract infections within 30 days before the study
- •8.Rhinitis related to anatomic problems (polyps, septum deviation, etc.).
- •9.Patients with severe physical nasal obstruction or injury, nasal ulcers, recent nasal surgery, asthma, rhinitis medicamentosa, acute or chronic sinusitis, glaucoma, cataract, any psychiatric disorder, adrenal insufficiency, prostatism, diabetes mellitus and bacterial or viral infection within 2 weeks of participation in the study.
- •10.Patient with known and current use of alcohol or drug addiction.
- •11.Patient with previous participation in any clinical trial in past 3 months.
- •12.Any condition or concurrent severe disease that may preclude the patient from taking part in the clinical trial as per Investigatorâ??s discretion.
研究者
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