Conditions: Vasomotor Rhinitis Seasonal Allergic Rhinitis
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 331
Healthy volunteers: no

Brief summary:
This is a randomized, two-way crossover, multicenter study evaluating the consumer preference of Phenylephrine Extended Release Tablets, 30 mg to be taken as one tablet every 12 hours, or Phenylephrine Immediate Release Tablets, 10 mg to be taken as one tablet every 4 hours in subjects with at least mild allergic rhinitis and nasal congestion. Approximately 250 participants will complete a questionnaire after taking one test product for 3 days followed by a 3 day (± 1 day) washout period; and then taking the alternate test product for 3 days. Analysis of which product the consumer preferred, if any, and which product was more convenient, if any, will be evaluated.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg intervention 2: Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg
Intervention descriptions: intervention 1: Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days. intervention 2: Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.

Protocol document: