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A Randomized, Two-Way Crossover, Multicenter, Consumer Preference Study of Two Oral Formulations of Phenylephrine Hydrochloride.
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.
Details
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 331 |
| Start date | 2009-08 |
| Completion | 2009-11 |
Conditions
- Vasomotor Rhinitis
- Seasonal Allergic Rhinitis
Interventions
- Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg
- Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg
Primary outcomes
- Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion — Visit 6 (Period 2, Day 4)
Preference was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Which product, if any, did you prefer for the relief of nasal congestion? The possible answers were: * I preferred the relief of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet) * I preferred the relief of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet) or • I did not have a preference