Vasomotor RhinitisPhase 3NCT00976209
Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)
A Phase 3 study testing Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg and Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg in people with Vasomotor Rhinitis and Seasonal Allergic Rhinitis, run by Bayer.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasomotor Rhinitis, Seasonal Allergic Rhinitis
- What is being tested?
- Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg and Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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, procedures or participation.
- Participants must agree not to take monoamine oxidase inhibitor (MAOI) for 14 days before study participation and 14 days after the end of the study.
- Participants must be willing to give written informed consent (prior to any study related procedures being performed) and able to adhere to restrictions and examination schedules.
- Female participants of childbearing potential (a non-menopausal female who has not had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure, including a young woman who has not yet started menstruating) must be using medically acceptable (documented failure rate of less than 1%) birth control measures. Examples of medically acceptable contraception include hormonal contraceptives, intrauterine device (IUD), double-barrier method (any combination of male or female condom, diaphragm, spermicidal gel, sponge) or sterilization.
- Participants must be able to read and write English, and must understand the dosing schedule.
Who cannot join
- Participants must not have any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of phenylephrine HCl, might interfere with the study or requires treatment expected to affect the blood pressure. These may include thyroid disease (e.g. hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy, etc.
- Participants that have received allergen immunotherapy or Xolair (omalizumab) therapy within the past two years.
- Participants who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration.
- Participants who have participated in a clinical trial of an investigational treatment within 30 days prior to the start of the study (Run-in Period Day 1).
- Participants who are, appear to be, or are known to be, current or former addicts or alcoholics.
- Participants who have a known allergy or intolerance to phenylephrine HCl, any other decongestant, loratadine, desloratadine or any other antihistamine.
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- Females who are pregnant, nursing or unwilling to use/practice medically acceptable contraception (documented failure rate of less than 1%).
- Participants with a history of asthma, rhinitis medicamentosa, or acute or chronic sinusitis.
- Participants that have used use of inhaled, oral, rectal, topical, intramuscular, and/or intravenous potent chronic or intermittent corticosteroids (up to 1% topical hydrocortisone is permitted).
- Participants who work at the study site and/or for the Investigator or are family members of study staff and/or the Investigator.
About this study
Official title: 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.
- Conditions
- Vasomotor Rhinitis, Seasonal Allergic Rhinitis
- Being tested
- Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg, Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg
- Medical subject headings
- Rhinitis, Vasomotor, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mgDrug
Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days.
Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mgDrug
Also called Sudafed PE®
Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine Hydrochloride Extended Release Tablets, 30 mg | Experimental | Not described Receives: Drug: Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg |
| Phenylephrine Hydrochloride Immediate Release Tablets, 10 mg | Active comparator | Not described Receives: Drug: Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: Visit 6 (Period 2, Day 4)
Secondary outcomes (1)
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
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
Measured: Visit 6 (Period 2, Day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vasomotor RhinitisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976209
- Sponsor's protocol ID
- 18122
- Other IDs
- CL2008-15, P07530
- Status last verified
- Feb 2015
- First submitted
- 11 Sep 2009
- Last updated
- 11 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two-Way Crossover, Multicenter, Consumer Preference Study of Two Oral Formulations of Phenylephrine Hydrochloride.
- ClinicalTrials.gov ID
- NCT00976209
- Acronym / sponsor ID
- 18122
- Conditions
- Vasomotor Rhinitis, Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 14 Sep 2009 (estimated)
- Results
- Posted 25 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine Hydrochloride Extended Release Tablets, 30 mg | Experimental | Drug: Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg |
| Phenylephrine Hydrochloride Immediate Release Tablets, 10 mg | Active comparator | Drug: Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (10 listed)
- Participants must not have any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of phenylephrine HCl, might interfere with the study or requires treatment expected to affect the blood pressure. These may include thyroid disease (e.g. hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy, etc.
- Participants that have received allergen immunotherapy or Xolair (omalizumab) therapy within the past two years.
- Participants who have a history of any clinically significant local or systemic infectious disease within four weeks prior to initial treatment administration.
- Participants who have participated in a clinical trial of an investigational treatment within 30 days prior to the start of the study (Run-in Period Day 1).
- Participants who are, appear to be, or are known to be, current or former addicts or alcoholics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mgPhenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days. | Drug | Phenylephrine Hydrochloride Extended Release Tablets, 30 mg |
| Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mgAlso: Sudafed PE®Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days. | Drug | Phenylephrine Hydrochloride Immediate Release Tablets, 10 mg |
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
1 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg and Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg in people with Vasomotor Rhinitis and Seasonal Allergic Rhinitis, run by Bayer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.