A Study Assessing the Safety and Effectiveness of FEX60/PE10 Fixed Combination Tablet in Patients With Allergic Rhinitis

Phase 3

Completed

• Conditions: Rhinitis Allergic
• Interventions: Drug: FEX60/PE10

• Registration Number: NCT02401191
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To assess the safety of twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10) combination tablet in patients with allergic rhinitis.

Secondary Objective:

To evaluate the effectiveness of a twice-daily FEX60/PE10 combination tablet on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), and daily activity impairment.

Detailed Description

It will be 22 days at minimum and up to 32 days depending on screening, treatment, and post-treatment observation allowances.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-27
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-26
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FEX60/PE10	FEX60/PE10	Internal use of FEX60/PE10 combination tablet will be administered twice daily (1 tablet per intake) for 2 weeks

Primary Outcome Measures

Name	Time	Method
Number of adverse events (Solicited AE reporting)	From intake of FEX60/PE10 up to approximately 2 weeks
Changes from baseline in the nasal congestion score based on the patient's symptom diary	After 2 weeks treatment

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the total score of 3 nasal symptoms (sneezing, rhinorrhea, and nasal congestion)	After 2 weeks treatment
Change in the total score of 3 nasal symptoms on a daily basis	After 2 weeks treatment
Change in the total score of 3 nasal symptoms during daytime	After 2 weeks treatment
Change in the total score of 3 nasal symptoms during night-time	After 2 weeks treatment
Change in the daily activity impairment score	After 2 weeks treatment
Change in the daily activity impairment score on a daily basis	After 2 weeks treatment
Change in the daily activity impairment score during daytime	After 2 weeks treatment
Change in the daily activity impairment score during night-time	After 2 weeks treatment
Change in nasal findings from baseline: color of inferior turbinate mucosa	After 2 weeks treatment
Change in nasal findings from baseline: congestion of inferior turbinate mucosa	After 2 weeks treatment
Change in nasal findings from baseline: consistency of discharge	After 2 weeks treatment
Assessment of patient's impression after treatment based on patient's symptom diary	After 2 weeks treatment

Trial Locations

Locations (1)

Sanofi Administrative Office; 🇯🇵 Tokyo, Japan