Conditions: Rhinitis Seasonal Rhinitis
Keywords: Seasonal allergies
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 539
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: Phenylephrine HCl intervention 2: Placebo intervention 3: Loratadine
Intervention descriptions: intervention 1: 10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days intervention 2: Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days intervention 3: 10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period.

Protocol document: