Comparative Efficacy, Safety and Tolerability of Olopatadine Extended Release Tablets and Olopatadine Immediate Release Tablets in the Treatment of Seasonal Allergic Rhinitis - A Randomized, Double-Blind Study.

Ranbaxy Laboratories Ltd16 个研究点分布在 1 个国家目标入组 200 人开始时间: 2011年1月20日最近更新: 2013年1月3日

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 200
试验地点: 16
主要终点: Percent change in the total nasal symptom score (TNSS) over baseline

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomized, double-blind, comparative study with an objective to compare the efficacy, safety and tolerability of Olopatadine 10 mg extended release tablet once daily with Olopatadine 5 mg immediate release tablets twice daily for a period of 10 days for treatment of seasonal allergic rhinitis. The study is being conducted at 16 centres all over in India. The primary outcome is percent change in the total nasal symptom score (TNSS) over baseline and the secondary outcomes are responder rate [defined as number of subjects having ≥ 50% reduction in total nasal symptom score (TNSS) over baseline] and assessment of medication effectiveness* by investigator and subject using 5 point scale (1 = complete relief, 2 = marked relief, 3 = moderate relief, 4 = slight relief, 5 = no relief/worse).

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant, Investigator and Outcome Assessor Blinded

入排标准

入选标准

•Inclusion Criteria:
•Subjects who have given written informed consent to participate in the study.
•Subjects of either sex aged between 18 to 65 years (both inclusive) with a history of SAR for ≥ 1 year.
•At the time of the enrollment subject should have an investigator assessed:(i) Total Nasal Symptom Score* of 4 -10 (both inclusive) and (ii) Nasal stuffiness score of ≤
•*Total Nasal Symptom Score (TNSS) will include assessment of rhinorrhoea, nasal stuffiness, nasal itching and sneezing using a 4-point scale for each (0 = no symptoms, 1= mild, 2 = moderate, 3 = severe).

排除标准

•Exclusion Criteria:
•Subjects with history of hypersensitivity to olopatadine or other antihistamines or any of the excipients of study formulations.
•Subjects with history of upper respiratory tract infection (including otitis media) within 14 days prior to enrollment or history of sinusitis within 30 days prior to enrollment.
•Subjects with nasal structural abnormalities (including deviated nasal septum, nasal polyps etc.).
•Subjects with nasal, ocular or sinus surgery in past 6 months.
•Subjects with history of disorders of nasolacrimal drainage.
•Subjects with rhinitis medicamentosa (defined as a condition characterized by nasal congestion without rhinorrhea or sneezing that is triggered by the use of topical nasal decongestants for more than 4-6 days).
•Subjects receiving immunotherapy except those on stable maintenance therapy for at least 6 months prior to enrollment in this study.
•Subjects who have received intranasal/systemic corticosteroids in the past 4 weeks or cromolyn sodium in the last 2 weeks.
•Subjects who have received astemizole in the past 4 weeks, loratadine/ desloratadine in the past 10 days, other oral/topical antihistamines or oral/topical nasal decongestants in the last 3 days.
•Subjects who require concomitant use of drugs which can interfere with study evaluation including CNS depressants.
•Subjects who would be requiring concomitant chronic or intermittent use of oral, intravenous, intramuscular, topical or inhaled corticosteroids.
•Subjects with significant disease(s) or disorder(s) other than seasonal allergic rhinitis that in the opinion of the investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subject?s ability to participate in the study.
•Subjects with history of substance abuse as per DSM IV criteria.
•Pregnant or breast-feeding women or women of child-bearing potential not using medically acceptable methods of contraception or women with positive serum pregnancy test at screening.
•Subjects with creatinine clearance of ≤ 35 mL/min (estimated from serum creatinine using the Cockcroft-Gault formula*).
•Subjects with SGOT/AST, SGPT/ALT or alkaline phosphatase ≥2 times upper limit of normal (ULN), or total bilirubin ≥ 1.5 times ULN.
•Subjects who are unable or unwilling to comply with the study procedures.
•Subjects who have participated in another investigational study within the last 3 months prior to entry in this study.
•Subjects who are likely to travel outside the study area for a substantial portion of the study period.
•Subjects involved in hazardous tasks such as driving or operating machinery.*Creatinine clearance (Cockcroft ?
•Gault formula)= [140 ?
•age (years)] x weight (kg)------------------------------------------------ (x 0.85 for female subjects) 72 x serum creatinine (mg/dL).

结局指标

主要结局

Percent change in the total nasal symptom score (TNSS) over baseline

时间窗: At the end of 10±2 days

次要结局

- Responder rate [defined as number of subjects having ≥ 50% reduction in total nasal symptom score (TNSS) over baseline](At the end of 10±2 days)
- Assessment of medication effectiveness* by investigator and subject*Medication effectiveness rating will be done using 5 scale: (1 = complete relief, 2 = marked relief, 3 = moderate relief, 4 = slight relief, 5 = no relief/worse)(At the end of 10±2 days)

研究者

发起方

Ranbaxy Laboratories Ltd

申办方类型

Pharmaceutical industry-Indian

研究点 (16)

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