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phenylephrine

Phase 1

Rhinitis | Small molecule | Respiratory |Johnson & Johnson|Last Updated: Oct 6, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

phenylephrine · 1 trial · 1 indication

Phase 1 1
NCT00762567Phenylephrine Pediatric Pharmacokinetic StudyRhinitis
COMPLETED36 Analytics
PHASE1COMPLETED
Phenylephrine Pediatric Pharmacokinetic Study
RhinitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetic Parameters
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 Endpoints

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.
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.
throughout duration of the study + 2 days (+30 days for spontaneously reported SAEs)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALphenylephrine

Interventions

NameTypeDescription
phenylephrine HClDRUGA single dose of a liquid dosage form of phenylephrine HCl 2.5mg/5mL, using a weight-age dosing schedule
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Eligibility Criteria

Age Range2 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 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 ...

Countries:United States
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Competitive Landscape -Allergic Rhinitis 4 trials (matched to "Rhinitis")

Frequently asked questions about phenylephrine

What is phenylephrine used for?

Phenylephrine is used for rhinitis, a condition involving inflammation of the nasal passages. It is being studied as a small molecule treatment in the respiratory therapeutic area. The drug is currently in Phase 1 clinical development and is being investigated for its effects in patients with rhinitis.

What does phenylephrine target?

Phenylephrine is a small molecule that acts as a decongestant. It works by constricting blood vessels in the nasal passages, which reduces swelling and congestion associated with rhinitis. This mechanism helps to relieve nasal symptoms by decreasing blood flow to the inflamed tissues.

Who makes phenylephrine?

Phenylephrine is being developed by Johnson & Johnson, a multinational pharmaceutical company. The company is listed on the stock exchange under the ticker symbol JNJ. Johnson & Johnson is conducting clinical research to evaluate the safety and efficacy of phenylephrine for the treatment of rhinitis.

What phase is phenylephrine in?

Phenylephrine is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 1 trial is focused on evaluating the drug's pharmacokinetics, which involves studying how the drug is absorbed, distributed, metabolized, and excreted in the body.

What clinical trials is phenylephrine in?

Phenylephrine has been studied in a Phase 1 clinical trial with the identifier NCT00762567, titled 'Phenylephrine Pediatric Pharmacokinetic Study'. This trial was conducted in the United States and enrolled 36 participants with rhinitis. The study has been completed and was not randomized or double-blinded.

Is phenylephrine the same as other decongestants?

Phenylephrine is a decongestant that works by narrowing blood vessels in the nasal passages to reduce swelling and congestion. It is similar to other decongestants like pseudoephedrine, but it has a different chemical structure and mechanism of action. Phenylephrine is commonly used in over-the-counter cold and allergy medications.