NCT01413958

Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1)

A Randomized, Placebo-Controlled Trial to Evaluate the Effects of Phenylephrine HCl 30 mg Extended-Release Tablets on Nasal Congestion in Subjects With Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 575 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the nasal congestion symptom relief of phenylephrine extended release tablets and placebo in participants with allergic rhinitis.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Phenylephrine	Phenylephrine hydrochloride 30-mg extended-release tablets, one tablet every 12 hours for 7 days
DRUG	Placebo	Placebo to phenylephrine hydrochloride 30-mg extended release tablets, one tablet every 12 hours for 7 days
DRUG	Loratadine	Loratadine, 10 mg, once daily as rescue medication, only if needed for intolerable allergic rhinitis symptoms

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-08-10
• Last updated: 2015-03-11
• Results posted: 2013-01-29