drugset / Trial / NCT00976209

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

NCT00976209

Phase 3 Completed 331 enrolled Bayer
RandomizedCrossoverSingle-blindTreatment

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.

Timeline

Start
2009-08
Primary completion
2009-11
Completion
2009-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Phenylephrine Small molecule 10 mg Oral
Subject Phenylephrine Small molecule 30 mg Oral