- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00976209
Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)
A Randomized, Two-Way Crossover, Multicenter, Consumer Preference Study of Two Oral Formulations of Phenylephrine Hydrochloride.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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, 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phenylephrine Hydrochloride Extended Release Tablets, 30 mg
|
Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days.
|
Active Comparator: Phenylephrine Hydrochloride Immediate Release Tablets, 10 mg
|
Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
or • I did not have a preference |
Visit 6 (Period 2, Day 4)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
or • I did not have a preference |
Visit 6 (Period 2, Day 4)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Rhinitis, Vasomotor
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- 18122
- CL2008-15
- P07530 (Other Identifier: Merck)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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