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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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