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

PHASE3CompletedINTERVENTIONAL
Enrollment

575

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

October 31, 2011

Study Completion Date

October 31, 2011

Conditions
Seasonal Allergic Rhinitis
Interventions
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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY