NCT01330017

Effects of Phenylephrine on Nasal Congestion in Participants With Seasonal Allergic Rhinitis (P08156 AM2)(Completed)

A Randomized, Dose-ranging, Placebo-controlled Trial to Evaluate the Effects of Phenylephrine HCl Immediate Release Tablets on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 539 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial will evaluate the nasal congestion symptom relief of the approved 10 mg phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with placebo in participants with histories of seasonal allergic rhinitis, using loratadine as background medication.

Conditions

• Rhinitis
• Seasonal Rhinitis

Interventions

Type	Name	Description
DRUG	Phenylephrine HCl	10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days
DRUG	Placebo	Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days
DRUG	Loratadine	10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-05-01
• Completion: 2011-06-01
• First posted: 2011-04-06
• Last updated: 2015-03-11
• Results posted: 2012-11-07