Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P0… (NCT00976209) | Clinical Trial Compass
CompletedPhase 3
Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)
331 participantsStarted 2009-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Healthy male or female volunteers must be 18 years or older.
* Participants must be willing to stop use of current decongestant and allergy medications during the study, and at the start of the run-in period (Visit 2).
* Participants must have a documented history of allergic rhinitis caused by ragweed allergen for at least the prior two years.
* Participants must have a documented skin testing (prick with wheal \>= 3 mm larger than the diluent or intradermal with wheal \>=7 mm larger than the diluent control) or a positive in vitro test for specific IgE to the ragweed allergen within the last four years.
* Participants must have signs by clinical evaluation and symptoms of nasal congestion of at least mild severity (sign/symptom clearly present, but minimal awareness; easily tolerated) at Visit 3 following the run-in period and at visit 5 following the washout period.
* Clinical laboratory tests (complete hematology, blood chemistries, urinalysis) must be within normal limits or clinically acceptable to the Investigator/Sponsor. Sponsor will not grant waivers.
* Participants must have a seated (after 5 minutes of rest) systolic/diastolic blood pressure ≤ 138/88 mmHg.
* Participants must have normal or clinically acceptable physical exam and electrocardiogram (ECG) on 12-lead ECG (recorded at 25 mm/s).
* Participants must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations, procedu…
What they're measuring
1
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