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Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold

Randomized, Double-blind, Placebo-Controlled Study of the Efficacy of Phenylephrine HCL Extended-Release 30 mg and Phenylephrine HCL Immediate-Release 12 mg Capsules in Subjects With Nasal Congestion Due to the Common Cold

NCT03339726•Johnson & Johnson Consumer Inc. (J&JCI)

View on ClinicalTrials.gov

Summary

This will be a randomized, double-blind, placebo controlled, parallel-group Phase 2 study to evaluate the efficacy of a new formulation of phenylephrine HCl and a currently marketed phenylephrine HCl for relief of nasal congestion in subjects with naturally occurring cold symptoms.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provide a signed and dated informed consent form before any study-related procedures.
•2. Men or non-pregnant, non-lactating women, aged 18 years or older, who have cold symptoms due to an acute upper respiratory tract infection but are otherwise healthy
•3. Have experienced onset of common cold symptoms (per subject report) within 72 hours before study entry consisting of cold symptoms per the following:
•1. At Visit 1, at least moderate severity (score ≥ 5, on a scale from 0 = none to 7 = severe) for stuffy/congested nose, and
•2. At Visit 1, at least mild (score ≥ 3, on a scale from 0 = none to 7 = severe) for sinus pressure/tenderness, and
•3. Within the past 72 hours, two or more of the following symptoms: runny nose, sore or scratchy throat, sneezing, headache, malaise, or cough.
•4. Are normotensive and have no clinically significant abnormalities identified by medical history or vital sign measurement (except as consistent with the diagnosis of the common cold) as determined by the Investigator at screening.
•* Blood pressure must be within the following limits after sitting for approximately 5 minutes: \> 90 and \<140 mm Hg systolic, and \>50 and \<90 mm Hg diastolic, at screening
•* Pulse rate \>50 and \<90 beats/minute at screening;
•* Body Mass Index (BMI) of 18 to 34 kg/m2 (inclusive);
+5 more criteria

Exclusion Criteria

•1. Currently experiencing nasal congestion due to allergic rhinitis or chronic respiratory disease.
•2. Any ear, nose, throat, or respiratory tract disease, other than the common cold, identified by signs and symptoms reported by the subject, or by medical history or medication history
•3. Presence of asthma.
•4. History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, or chronic sleep apnea.
•5. Fever of ≥ 101.0 °F (38.3 °C).
•6. Heart disease, controlled or uncontrolled hypertension, thyroid disease, diabetes, glaucoma, prostatic hypertrophy, or presence of a disease, which in the opinion of the investigator, would preclude the use of phenylephrine.
•7. Are currently taking, or have taken within two weeks of screening, a monoamine oxidase inhibitor (MAOI).
•8. Have the need to use medications which may impact nasal symptomatology i.e. systemic, inhaled (oral or nasal) corticosteroids, and the following drugs with significant anticholinergic properties: tricyclic antidepressants, paroxetine, medicines used to treat overactive bladder, antipsychotic medication, skeletal muscle relaxants, antiparkinsonian medication, the anticonvulsants carbamazepine and oxcarbazepine, and dicycloverine (dicyclomine), dimenhydrinate, propantheline, atropine, hyoscyamine, belladonna, prochlorperazine and promethazine.
•9. Have a bacterial sinus infection within 2 weeks prior to screening.
•10. Use of systemic antibiotics within the past 7 days prior to screening.
+16 more criteria

Locations (11)

The Medical Arts Health Research Group

Kelowna, British Columbia, Canada

Mission Hills Urgent Care Walk in Clinic

Mission, British Columbia, Canada

James Lai, MD, Inc

Vancouver, British Columbia, Canada

NEOMO Research

Greater Sudbury, Ontario, Canada

Dawson Road Family Medical Clinic

Guelph, Ontario, Canada

Sunningdale Health and Wellness Centre

London, Ontario, Canada

Bluewater Clinical Research Group, Inc.

Sarnia, Ontario, Canada

Canadian Phase Onward, Inc.

Toronto, Ontario, Canada

PrimeHealth Clinical Research

Toronto, Ontario, Canada

Diex Recherche

Sherbrooke, Quebec, Canada

Key Dates

Start Date

November 30, 2017

Primary Completion Date

April 16, 2018

Completion Date

April 16, 2018

Last Updated

June 4, 2019

Enrollment

193

ACTUAL participants

Conditions

Common Cold

Interventions

New Formulation Phenylephrine HCl

DRUG

Marketed Phenylephrine HCl

DRUG

Placebo

DRUG

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NCT06531707

Common Cold

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COMPLETEDPHASE4

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UNKNOWN

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold

Inclusion Criteria

Exclusion Criteria

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