NCT00976209

Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)

A Randomized, Two-Way Crossover, Multicenter, Consumer Preference Study of Two Oral Formulations of Phenylephrine Hydrochloride.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vasomotor Rhinitis
• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg	Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days.
DRUG	Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg	Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-09-14
• Last updated: 2015-03-11
• Results posted: 2011-03-25