A multi-centric, randomized, double blind, parallel group, active controlled, comparative Phase III clinical trial to evaluate the efficacy and safety of FDC of Bepotastine besilate 10mg/10mg + Montelukast sodium 5mg/10mg tablet versus Montelukast Sodium 5mg and Montelukast Sodium 10mg tablet in subjects diagnosed with Allergic Rhinitis.

Windlas Biotech Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Subjects who meet the following criteria are eligible for inclusion in the study:
•1.Subject who agrees for giving informed consent and provide signed and dated written IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures.
•2.Male and Female subjects of group age >=18 to <=65 years.
•3.Patient with symptoms of allergic rhinitis characterized by nasal pruritus, sneezing, rhinorrhea, and nasal congestion.
•4.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.
•5.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.
•6.Written informed consent signed by patient and willing to comply with the study procedure.
•7.Female patient of childbearing potential definitely using effective contraception during the study and willing to undergo pregnancy test.

•1.Subjects who are not able to or not willing to sign an IRB/IEC approved consent form.
•2.Patients with known hypersensitivity to the study categories of medications.
•3.Pregnant and lactating female patient.
•4.Patient with known history of hypersensitivity to Bepotastine tablet or its components.
•5.Patients receiving oral or topical H1 receptor antagonists within the last 48 hrs of enrolment.
•6.Patients receiving antiallergic or antipruritic agents, antihistamines, corticosteroids, NSAIDs, tranquillizers and cold remedies within three days prior to the study.
•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 1 month.
•12.Any condition or concurrent severe disease that may preclude the patient from taking part in the clinical trial as per Investigatorâ??s discretion.

发起方

Windlas Biotech Pvt Ltd