drugset / Trial / NCT05720455

Study to Assess Safety and Efficacy of Fexofenadine Hydrochloride (HCL) + Pseudoephedrine HCL Fixed Dose Combination in Indian Male and Female Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above

NCT05720455

Phase 4 Completed 203 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2025-06-15
Primary completion
2025-12-05
Completion
2025-12-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Fexofenadine Unknown 60 mg Oral
Subject Pseudoephedrine Small molecule 120 mg Oral

Indications