Trials / Completed
CompletedNCT02401191
A Study Assessing the Safety and Effectiveness of FEX60/PE10 Fixed Combination Tablet in Patients With Allergic Rhinitis
A Non-controlled, Open Study for Assessing the Safety and Effectiveness of a Twice-daily FEX 60 mg - PE 10 mg (FEX60/PE10) Fixed Combination Tablet in Patients With Allergic Rhinitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 15 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FEX60/PE10 | Pharmaceutical form:tablet Route of administration: oral |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2015-07-01
- Completion
- 2015-07-01
- First posted
- 2015-03-27
- Last updated
- 2015-11-30
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02401191. Inclusion in this directory is not an endorsement.