Health Condition 1: null- Patients of Allergic Rhinitis
Conditions
Interventions
Intervention1: Bepotastine 10 mg tablet
: Twice daily for 4 weeks
Control Intervention1: Fexofenadine 60 mg tablet
: Twice in day for 4 weeks
Sponsors
Lupin Limited India
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Total Nasal Symptom Score (TNSS) and Total Ocular Symptom Score (TOSS). 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in TNSS, TOSS and individual nasal and ocular symptom scores at the end of study as compared to baseline. 2) Rhinocojunctivitis Quality of Life Questionnaire (RQOL) at the end of study as compared to baseline. 3) Mean Change in Six Digits Cancellation Test for Psychomotor Performance score at the end of study as compared to baseline. 4) Investigatorâ??s Global assessment of the treatment. 5) Patientâ??s Global assessment of the treatment. Timepoint: For TNSS, TOSS, TSS, RQOL and Six Digits Cancellation Test for Psychomotor Performance. Time points are- Day 1 (V1), Day 10±2 (v2), Day 20±2 (V3) and Day 28±2 (v4). For Investigatorâ??s Global assessment of the treatment and Patientâ??s Global assessment of the treatment. Time Point is- Day 28±2 (v4). | — |
Countries
India
Contacts
Public ContactMs Manisha M Banavalikar
Lupin Limited, India
Outcome results
None listed