RhinitisPhase 1NCT00762567
Phenylephrine Pediatric Pharmacokinetic Study
A Phase 1 study testing phenylephrine HCl in people with Rhinitis, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
Trial summary
To characterize the pharmacokinetics of phenylephrine in two pediatric populations: children, ages 2 to <12 years, and adolescents, ages 12 to <18 years. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Rhinitis
- What is being tested?
- phenylephrine HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Nov 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female children and adolescents, ages 2 to < 18 years, with a minimum weight of 24 pounds will be eligible to participate. In addition, each subject will be > 5th percentile and < 95th percentile for weight based on age and gender.
- Subjects will have a body mass index (BMI) > 5th percentile and less than or equal to the 90th percentile for age and gender.
- Subjects who have a history of allergic rhinitis and who are experiencing nasal symptoms associated with hay fever or other upper respiratory allergies will be included.
- Subjects and parents or legally authorized representatives who, in the investigator's view, are likely to be compliant and complete the study will be eligible to participate.
- Post menarchal female subjects must have a negative urine pregnancy test at screening and at Visit 2 on Day 1 before study medication is administered.
- Post menarchal female subjects must have practiced abstinence or use an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least three months before being enrolled in the study.
- Parents or legally authorized representatives have signed and dated an IRB-approved consent form for the subject to participate in the study indicating that the subject (and/or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Subjects, ages 6 to < 18 years, who have provided written assent to participate in the study
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease.
- Findings from the medical history or physical examination with vital sign measurements that are not within the range of clinical acceptability.
- Have a known sensitivity or allergy to phenylephrine or EMLA cream.
- Took any prescription or nonprescription medication (except vitamins and/or fluoride supplements) within seven days before the study's start date.
- Drank any fruit juices (i.e., apple, orange, or grapefruit) within two days prior to the study start.
- Use of any monoamine oxidase inhibitor within two weeks prior to the dose of phenylephrine.
Show all 12Show fewer
- Participated in, or completed, another clinical trial within seven weeks before the study's start date.
- Have a history of drug, alcohol, and tobacco use (older children and adolescents).
- Have a history of hepatitis B, a previous positive test for hepatitis B surface antigen, or a previous positive hepatitis C antibody.
- Have a history of HIV infection or previous demonstration of HIV antibodies.
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception from at least three months prior to the first dose of study medication until completion of follow-up procedures.
- Relationship to persons involved directly with the conduct of the study (ie, principal investigator; subinvestigators; study coordinators; other study personnel; employees or contractors of the sponsor or its subsidiaries; and the families of each).
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Clinical Trials
Cypress, California, 90630
About this study
Official title: An Open-Label, Single-Dose Study Evaluating the Pharmacokinetics of Phenylephrine in Children and Adolescents
To characterize the pharmacokinetics of phenylephrine in two pediatric populations: children, ages 2 to <12 years, and adolescents, ages 12 to <18 years.
Read the detailed description
This study has an open-label, single-dose classical pharmacokinetic design with no comparator treatment or group. At least twenty-four (24) children, ages 2 to <12 years, and twelve (12) adolescents, ages 12 to <18 years, with nasal symptoms due to hay fever or other upper respiratory allergies will complete the study. To ensure that younger children are represented, at least 35% (8) of the 24 children enrolled will range from 2 to <6 years of age.
- Conditions
- Rhinitis
- Being tested
- phenylephrine HCl
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenylephrine HClDrug
Also called Children's Sudafed PE Nasal Decongestant Liquid
A single dose of a liquid dosage form of phenylephrine HCl 2.5mg/5mL, using a weight-age dosing schedule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | phenylephrine Receives: Drug: phenylephrine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameters
Measured: 10, 20, 30, 45, and 60 minutes, and at 1.5, 2, 2.5, 3, and 3.5 hours after the dose. For children >6, an additional blood sample will be collected at 4.5 hours after dosing
Secondary outcomes (2)
For children 5 years and older and adolescents, the total amount of phenylephrine and its metabolites excreted, percent of the administered dose will be estimated from the urine samples along with the formation clearance of each metabolite.
Measured: 24 hours
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.
Measured: throughout duration of the study + 2 days (+30 days for spontaneously reported SAEs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhinitisStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dolly Parasrampuria, PhD, Study director, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762567
- Sponsor's protocol ID
- PHEALY1006
- Status last verified
- Oct 2011
- First submitted
- 26 Sep 2008
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Gelotte CK, Parasrampuria DA, Zimmerman BA. Single-Dose Pharmacokinetics and Metabolism of the Oral Decongestant Phenylephrine HCl in Children and Adolescents. Pulm Ther. 2023 Mar;9(1):139-150. doi: 10.1007/s41030-022-00206-8. Epub 2022 Dec 8.
PubMed 36480111
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose Study Evaluating the Pharmacokinetics of Phenylephrine in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00762567
- Acronym / sponsor ID
- PHEALY1006
- Conditions
- Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To characterize the pharmacokinetics of phenylephrine in two pediatric populations: children, ages 2 to <12 years, and adolescents, ages 12 to <18 years.
Detailed description
This study has an open-label, single-dose classical pharmacokinetic design with no comparator treatment or group. At least twenty-four (24) children, ages 2 to <12 years, and twelve (12) adolescents, ages 12 to <18 years, with nasal symptoms due to hay fever or other upper respiratory allergies will complete the study. To ensure that younger children are represented, at least 35% (8) of the 24 children enrolled will range from 2 to <6 years of age.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: phenylephrine HClphenylephrine |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male and female children and adolescents, ages 2 to < 18 years, with a minimum weight of 24 pounds will be eligible to participate. In addition, each subject will be > 5th percentile and < 95th percentile for weight based on age and gender.
- Subjects will have a body mass index (BMI) > 5th percentile and less than or equal to the 90th percentile for age and gender.
- Subjects who have a history of allergic rhinitis and who are experiencing nasal symptoms associated with hay fever or other upper respiratory allergies will be included.
- Subjects and parents or legally authorized representatives who, in the investigator's view, are likely to be compliant and complete the study will be eligible to participate.
- Post menarchal female subjects must have a negative urine pregnancy test at screening and at Visit 2 on Day 1 before study medication is administered.
Key exclusion criteria (12 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease.
- Findings from the medical history or physical examination with vital sign measurements that are not within the range of clinical acceptability.
- Have a known sensitivity or allergy to phenylephrine or EMLA cream.
- Took any prescription or nonprescription medication (except vitamins and/or fluoride supplements) within seven days before the study's start date.
- Drank any fruit juices (i.e., apple, orange, or grapefruit) within two days prior to the study start.
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 HClAlso: Children's Sudafed PE Nasal Decongestant LiquidA single dose of a liquid dosage form of phenylephrine HCl 2.5mg/5mL, using a weight-age dosing schedule | Drug | 1 |
Primary outcome
Pharmacokinetic Parameters
Time frame: 10, 20, 30, 45, and 60 minutes, and at 1.5, 2, 2.5, 3, and 3.5 hours after the dose. For children >6, an additional blood sample will be collected at 4.5 hours after dosing
2 secondary outcomes
For children 5 years and older and adolescents, the total amount of phenylephrine and its metabolites excreted, percent of the administered dose will be estimated from the urine samples along with the formation clearance of each metabolite.
Time frame: 24 hours
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.
Time frame: throughout duration of the study + 2 days (+30 days for spontaneously reported SAEs)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
- Derived from this study: PubMed 36480111Gelotte CK, Parasrampuria DA, Zimmerman BA. Single-Dose Pharmacokinetics and Metabolism of the Oral Decongestant Phenylephrine HCl in Children and Adolescents. Pulm Ther. 2023 Mar;9(1):139-150. doi: 10.1007/s41030-022-00206-8. Epub 2022 Dec 8.
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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.
Dolly Parasrampuria, PhD study director
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing phenylephrine HCl in people with Rhinitis, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
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 8 inclusion and 12 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 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetic Parameters (time frame: 10, 20, 30, 45, and 60 minutes, and at 1.5, 2, 2.5, 3, and 3.5 hours after the dose. For children >6, an additional blood sample will be collected at 4.5 hours after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00762567, which also lists 1 linked publication.
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 6 Oct 2011.