A comparative Phase III clinical trial to evaluate the efficacy and safety of FDC of Bepotastine besilate 10mg/10mg plus Montelukast sodium 5mg/10mg tablet versus Montelukast sodium 5mg and Montelukast sodium 10mg tablet in subjects diagnosed with Allergic Rhinitis.
- Conditions
- Upper respiratory tract hypersensitivity reaction, site unspecified,
- Registration Number
- CTRI/2019/09/021293
- Lead Sponsor
- Windlas Biotech Pvt Ltd
- Brief Summary
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 plus Montelukast Sodium 5mg/10mg Tablet versus Montelukast Sodium 5mg, Montelukast sodium 10mg tablet in subjects diagnosed with Allergic Rhinitis. The efficacy of both Bepotastine besilate 10mg/10mg plus Montelukast Sodium 5mg/10mg as well as Bepotastine besilate 10mg are tested and proven in the treatment of Allergic rhinitis (Nasal congestion, rhinorrhoea, nasal pruritus, sneezing) as per available clinical data. Therefore, we are conducting this prospective clinical trial to determine the safety and efficacy of Bepotastine 10mg/10mg plus Montelukast Sodium 5mg/10mg, Montelukast Sodium 5mg, Montelukast Sodium 10mg tablets in Indian subjects. It would be a multi-centric clinical trial. We will adopt the consecutive enrolment, wherein each patient will be screened and enrolled into the study if found eligible.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 240
- 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 Investigator’s discretion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy and safety of FDC of Bepotastine 10mg/10mg plus Montelukast Sod. 5mg/10mg in Indian patients diagnosed with Allergic Rhinitis. Treatment Phase from Day 1 (Week 1) to day 14 (Week 2)
- Secondary Outcome Measures
Name Time Method To evaluate the number of subjects whose Allergic Rhinitis alleviated to normal in both groups (Study and Active Control). Treatment Phase from Day 1 (Week 1) to day 14 (Week 2)
Trial Locations
- Locations (10)
All India Institute of Medical Sciences
🇮🇳Khordha, ORISSA, India
Anu Hospital
🇮🇳Krishna, ANDHRA PRADESH, India
Government Medical College and Government General Hospital
🇮🇳Srikakulam, ANDHRA PRADESH, India
JNUIMSRC
🇮🇳Jaipur, RAJASTHAN, India
Maharaja Agrasen Hospital
🇮🇳West, DELHI, India
Maulana Azad Medical College
🇮🇳Central, DELHI, India
Popular Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
R G Kar Medical College and Hospital
🇮🇳Kolkata, WEST BENGAL, India
Sharda hospital, SMSR, Sharda University
🇮🇳Nagar, UTTAR PRADESH, India
Sudbhawana Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
All India Institute of Medical Sciences🇮🇳Khordha, ORISSA, IndiaDr Debananda SahooPrincipal investigator8763290804genmeddebananda@aiimsbhubaneswar.edu.in