A clinical trial to study safety and efficacy of Bepotastine besilate in patient with allergic rhinitis.
- Conditions
- Health Condition 1: null- Patients of Allergic Rhinitis
- Registration Number
- CTRI/2015/10/006262
- Lead Sponsor
- upin Limited India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of Total Nasal Symptom Score (TNSS) and Total Ocular Symptom Score (TOSS). <br/ ><br>Change in Total Symptom Score (TSS; the sum of TNSS and TOSS) at the end of study as compared to baseline.Timepoint: Day 1 (V1), Day 10±2 (v2), Day 20±2 (V3) and Day 28±2 (v4) <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1) Change in TNSS, TOSS and individual nasal and ocular symptom scores at the end of study as compared to baseline. <br/ ><br>2) Rhinocojunctivitis Quality of Life Questionnaire (RQOL) at the end of study as compared to baseline. <br/ ><br>3) Mean Change in Six Digits Cancellation Test for Psychomotor Performance score at the end of study as compared to baseline. <br/ ><br>4) Investigatorâ??s Global assessment of the treatment. <br/ ><br>5) Patientâ??s Global assessment of the treatment. <br/ ><br>Timepoint: For <br/ ><br>TNSS, TOSS, TSS, RQOL and Six Digits Cancellation Test for Psychomotor Performance. <br/ ><br>Time points are- <br/ ><br>Day 1 (V1), Day 10±2 (v2), Day 20±2 (V3) and Day 28±2 (v4). <br/ ><br> <br/ ><br>For <br/ ><br>Investigatorâ??s Global assessment of the treatment and Patientâ??s Global assessment of the treatment. <br/ ><br>Time Point is- Day 28±2 (v4).