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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Bayer

Current Primary Outcome: 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 [ Time Frame: 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



Original Primary Outcome: Which product did you prefer for the relief of nasal congestion? Possible answers are: I preferred relief of Treatment A & every 12 hrs white tablet); I preferred relief of Treatment B (every 4 hours red tablet) Or I didn't have preference. [ Time Frame: After completion of questionnaire by subject following a 3 day treatment period of one test product, a 3 day(±1 day) washout period, and a 3 day treatment period of alternate test product. ]

Current Secondary Outcome: Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets [ Time Frame: Visit 6 (Period 2, Day 4) ]

Convenience 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:

Secondary Endpoint

Which product, if any, was more convenient?

The possible answers were:

  • I preferred the convenience of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet)
  • I preferred the convenience of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet)

or

• I did not have a preference



Original Secondary Outcome: Which product was more convenient? I preferred convenience of Treatment A (every 12 hours white tablet); I preferred convenience of Treatment B (every four hours red tablet: Or, I didn't have a preference. [ Time Frame: After completion of questionnaire by subject following a 3 day treatment period of one test product, a 3 day washout period, and a 3 day treatment period of alternate test product. ]

Information By: Bayer

Dates:
Date Received: September 11, 2009
Date Started: August 2009
Date Completion:
Last Updated: February 20, 2015
Last Verified: February 2015