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

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ClinicalTrials.gov Identifier: NCT03339726
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Common Cold Drug: New Formulation Phenylephrine HCl Drug: Marketed Phenylephrine HCl Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : April 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: New Formulation Phenylephrine HCl Drug: New Formulation Phenylephrine HCl
2 doses of one tablet 12 hours apart
Active Comparator: Marketed Phenylephrine HCl Drug: Marketed Phenylephrine HCl
4 doses of one capsule 4 hours apart
Placebo Comparator: Placebo Drug: Placebo
4 doses of placebo capsule and tablet taken 4 hours apart


Outcome Measures

Primary Outcome Measures :
  1. Average change from baseline in the Nasal Congestion Severity Score [ Time Frame: 0-12 hours ]
    Average change from baseline in the Nasal Congestion Severity Score on an 8 point scale with 0=None and 7=Severe


Secondary Outcome Measures :
  1. Average Change from baseline in the Nasal Congestion Severity Score [ Time Frame: 0-12 hours ]
    Average change from baseline in the Nasal Congestion Severity Score averaged over hours 8-12. This is an 8 point scale with 0=None and 7=Severe.

  2. Change from baseline in the Nasal Congestion Severity Score [ Time Frame: 0-2 hours ]
    Change from baseline in the Nasal Congestion Severity Score at 2 hours. This is an 8 point scale with 0=None and 7=Severe.

  3. Change from baseline in the Nasal Congestion Severity Score [ Time Frame: 0-4 hours ]
    Change from baseline in the Nasal Congestion Severity Score at 4 hours. This is an 8 point scale with 0=None and 7=Severe.

  4. Change from baseline in the Nasal Congestion Severity Score [ Time Frame: 0-6 hours ]
    Change from baseline in the Nasal Congestion Severity Score at 6 hours. This is an 8 point scale with 0=None and 7=Severe.

  5. Change from baseline in the Nasal Congestion Severity Score [ Time Frame: 0-8 hours ]
    Change from baseline in the Nasal Congestion Severity Score at 8 hours. This is an 8 point scale with 0=None and 7=Severe.

  6. Change from baseline in the Nasal Congestion Severity Score [ Time Frame: 0-10 hours ]
    Change from baseline in the Nasal Congestion Severity Score at 10 hours. This is an 8 point scale with 0=None and 7=Severe.

  7. Change from baseline in the Nasal Congestion Severity Score [ Time Frame: 0-12 hours ]
    Change from baseline in the Nasal Congestion Severity Score at 12 hours. This is an 8 point scale with 0=None and 7=Severe.

  8. Change from baseline in the Nasal Congestion Severity Score [ Time Frame: 0-24 hours ]
    Change from baseline in the Nasal Congestion Severity Score at 24 hours. This is an 8 point scale with 0=None and 7=Severe.

  9. Average Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-12 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores averaged over assessments at 2, 4, 6, 8, 10, and 12 hours. This is an 8 point scale with 0=None and 7=Severe.

  10. Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-2 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 2 hours. This is an 8 point scale with 0=None and 7=Severe.

  11. Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-4 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 4 hours.

  12. Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-6 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 6 hours. This is an 8 point scale with 0=None and 7=Severe.

  13. Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-8 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 8 hours. This is an 8 point scale with 0=None and 7=Severe.

  14. Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-10 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 10 hours. This is an 8 point scale with 0=None and 7=Severe.

  15. Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-12 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 12 hours. This is an 8 point scale with 0=None and 7=Severe.

  16. Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-24 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 24 hours. This is an 8 point scale with 0=None and 7=Severe.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18 years or older, who have cold symptoms due to an acute upper respiratory tract infection but are otherwise healthy
  2. Have experienced onset of common cold symptoms within 60 hours before study entry consisting of at least four cold symptoms:

    1. at least moderate severity for stuffy/congested nose;
    2. at least mild for sinus pressure/tenderness;
    3. at least two of the following symptoms: runny nose, sore or scratchy throat, sneezing, headache, malaise, or cough
  3. Willing to use only the study treatment for cold symptom relief during the course of the study; no other cough, cold, allergy, or analgesic/antipyretic medicines or herbal/dietary supplements will be permitted during the study
  4. Females of childbearing potential must have used an effective form of birth control for three months before Screening and a negative urine pregnancy test at the Screening visit.

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. History 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. History or presence of cardiovascular disease, thyroid disease, diabetes, glaucoma, prostatic hypertrophy, phaeochromocytoma or occlusive peripheral vascular disease
  7. Have a bacterial sinus infection within 2 weeks prior to screening.
  8. Use of systemic antibiotics within the past 7 days prior to screening.
  9. Before the first dose of study medicine, use of

    1. oral or intranasal cold, cough, allergy, or analgesic/antipyretic medicines within approximately 12 hours;
    2. menthol products, medicated lozenge, humidifier, nasal saline spray or throat spray within approximately 6 hours;
    3. herbal/dietary supplements within approximately 12 hours.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339726


Contacts
Contact: Michael Morris 441628827036 mmorris6@its.jnj.com
Contact: Janice Solla 215-273-7571 jsolla1@its.jnj.com

Locations
Canada, British Columbia
The Medical Arts Health Research Group Not yet recruiting
Kelowna, British Columbia, Canada, V1Y 4N7
Contact: Florence Hunter, RN    (250) 763-1791    flo@healthresearch.ca   
Principal Investigator: Robert Williams         
Mission Hills Urgent Care Walk in Clinic Recruiting
Mission, British Columbia, Canada, V2V 0C8
Contact: Tracey Roach    (604) 826-7751    tjroach75@gmail.com   
Principal Investigator: Antonio Del Vicario, MD         
Canada, Ontario
Dawson Road Family Medical Clinic Not yet recruiting
Guelph, Ontario, Canada, N1H 1B1
Contact: Adam DeRose    (226) 337-1841    aderose@dawsonclinicalresearch.com   
Principal Investigator: Garry Wallace, MD         
Sunningdale Health and Wellness Centre Not yet recruiting
London, Ontario, Canada, N6G 4W3
Contact: Amy Morley    (519) 859-9589    Amorley@viableclinicalresearch.com   
Principal Investigator: Altaf Mawji, MD         
Bluewater Clinical Research Group, Inc. Not yet recruiting
Sarnia, Ontario, Canada, N7T 4X3
Contact: Laura Croft    (519) 344-6612    laura@bwresearch.ca   
Principal Investigator: Sean Peterson, MD         
NEOMO Research Not yet recruiting
Sudbury, Ontario, Canada, P3E 6C3
Contact: Therese Vaillancourt, RPN    (705) 586-3601    therese@drdhatt.com   
Principal Investigator: James McKay, MD         
Canadian Phase Onward, Inc. Recruiting
Toronto, Ontario, Canada, M3J 2C5
Contact: Esmiralda Kazmin, MD    (416) 227-0543    mira.kazmin@phaseonward.com   
Principal Investigator: Lew Pliamm, MD         
PrimeHealth Clinical Research Recruiting
Toronto, Ontario, Canada, M4S 1Y2
Contact: Christabel Robinet    (416) 486-8444    Chris.robinet@rogers.com   
Principal Investigator: Iris Gorfinkel, MD         
Canada, Quebec
Diex Recherche Not yet recruiting
Sherbrooke, Quebec, Canada, J1H 1Z1
Contact: Maude Bilodeau, M.Sc.    (819) 346-2887    mbilodeau@diex.ca   
Principal Investigator: Ginette Girard, MD         
Diex Recherche Not yet recruiting
Victoriaville, Quebec, Canada, G6P 6P6
Contact: Chantal Lamontagne    (819) 260-1172    clamontagne@diex.ca   
Principal Investigator: Ethel Bellavance, MD         
Sponsors and Collaborators
Johnson & Johnson Consumer Inc. (J&JCI)
Investigators
Study Director: Michael Morris Johnson and Johnson Consumer, Inc
More Information

Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
ClinicalTrials.gov Identifier: NCT03339726     History of Changes
Other Study ID Numbers: CO-170302131230-URCT
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Phenylephrine
Oxymetazoline
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents