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 Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 200

研究概览入排标准研究者记录与标识符相似试验

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

•Inclusion Criteria:
•1. Subjects who have given written informed consent to participate in the study.
•2. Subjects of either sex aged between 18 to 65 years (both inclusive) with a history of SAR for ≥ 1 year.
•3. 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 ≤ 2.
•*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:
•1. Subjects with history of hypersensitivity to olopatadine or other antihistamines or any of the excipients of study formulations.
•2. 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.
•3. Subjects with nasal structural abnormalities (including deviated nasal septum, nasal polyps etc.).
•4. Subjects with nasal, ocular or sinus surgery in past 6 months.
•5. Subjects with history of disorders of nasolacrimal drainage.
•6. 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).
•7. Subjects receiving immunotherapy except those on stable maintenance therapy for at least 6 months prior to enrollment in this study.
•8. Subjects who have received intranasal/systemic corticosteroids in the past 4 weeks or cromolyn sodium in the last 2 weeks.
•9. 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. 10. Subjects who require concomitant use of drugs which can interfere with study evaluation including CNS depressants.
•11. Subjects who would be requiring concomitant chronic or intermittent use of oral, intravenous, intramuscular, topical or inhaled corticosteroids.
•12. 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.
•13. Subjects with history of substance abuse as per DSM IV criteria.
•14. 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.
•15. Subjects with creatinine clearance of ≤ 35 mL/min (estimated from serum creatinine using the Cockcroft-Gault formula*).
•16. Subjects with SGOT/AST, SGPT/ALT or alkaline phosphatase ≥2 times upper limit of normal (ULN), or total bilirubin ≥ 1.5 times ULN.
•17. Subjects who are unable or unwilling to comply with the study procedures.
•18. Subjects who have participated in another investigational study within the last 3 months prior to entry in this study.
•19. Subjects who are likely to travel outside the study area for a substantial portion of the study period.
•20. 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)

研究者

发起方

Ranbaxy Laboratories Ltd

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