This is a single group, Phase IV clinical trial to assess the safety and effectiveness of Allegra® D. This study will be conducted in participants with allergic rhinitis who are 12 years of age and above. The individual study duration for each participant would be approximately 16 days (maximum of 13 days intervention + a 3-day post intervention observation). There would be 4 study visits in which the last visit can be done either telephonically or on site. Safety events would be captured for the entire study duration. In addition, the effectiveness of the study drug would be assessed using Nasal symptom score (NSS) and Total symptom score (TSS).
The individual study duration for each participant would be approximately 16 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
203
Extended-Release Tablets
Misha ENT Hospital
Ahmedabad, Gujarat, India
Silver Touch Multispecialty Hospital
Ahmedabad, Gujarat, India
Pt B.D. Sharma, PGIMS
Rohtak, Haryana, India
Dr BR Ambedkar Medical College & Hospital
Bangalore, Karnataka, India
Belagavi Institute of Medical science
Belagavi, Karnataka, India
Sahyadri super speciality hospital
Pune, Maharashtra, India
Sum Ultimate Medicare
Bhubaneshwar, Odisha, India
Apex Hospital Private Limited
Jaipur, Rajasthan, India
Moti Lal Nehru Medical College
Allahābād, Uttar Pradesh, India
Swami Rama Himalayan University
Dehradun, Uttarakhand, India
...and 1 more locations
Number of participants with treatment-emergent adverse events (TEAEs)
A TEAE is defined as any adverse event (AE) that occur in between the first investigational medicinal product (IMP) administration (on Day 1) and Day 16.
Time frame: Day 1 to Day 16
Number of participants with treatment-emergent serious adverse events (SAEs)
A treatment-emergent SAE is defined as any SAE that occur in between the first investigational medicinal product (IMP) administration (on Day 1) and Day 16.
Time frame: Day 1 to Day 16
Mean change from baseline in Total Symptom Score (TSS)
The TSS is the sum of physician-assessed nasal symptom scores for sneezing; rhinorrhea; itchy nose, palate, and/or throat; itchy, watery eyes; and nasal congestion, each accessed on 0-4 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms and 4 = very severe symptoms). Higher score indicated more severe symptoms.
Time frame: Day 1, Day 13
Mean change from baseline in Nasal Congestion Score (NCS)
Nasal congestion was assessed by the physician on a 0-4 categorical scale, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms and 4 = very severe symptoms. Higher score indicated more severe symptoms.
Time frame: Day 1, Day 13
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