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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 : Suspended (did not enroll enough subjects in the 2017/2018 cold season)
First Posted : November 13, 2017
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

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 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, 2019
Estimated Study Completion Date : April 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold

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




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.



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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. Willing to use only the study treatment for cold symptom relief during the course of the study and avoid the use of treatments that may affect nasal / cold symptomatology; no other cough, cold, allergy, or analgesic/antipyretic medicines (non-prescription or prescription) or herbal/dietary supplements will be permitted during the study
  6. 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.
  7. Female and male subjects must agree to the contraceptive requirement use during the study and for at least 30 days after the last dose (for females) (See Section 10.4.3 ).
  8. Willing and able to comply with the study procedures and visit schedule, which includes remaining at the study site for at least 4 hours after the first dose of study medicine on Day 1.
  9. Able to read and understand English and/or French;

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.
  11. Known or suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates).
  12. Use of marijuana containing substances within the 10 days prior to screening and throughout the study.
  13. Positive Urine Drug Screen.
  14. Use of alcohol throughout the study.
  15. History of smoking tobacco products or use of nicotine-containing substances within the previous three months as determined by subject's medical history or subject's verbal report.
  16. Known sensitivity to the investigational product or any excipients of the drug product.
  17. 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.
  18. Have difficulty swallowing tablets/capsules or are unable to swallow whole without crushing, chewing, splitting, or dissolving.
  19. Subjects who were previously randomized and received the IP.
  20. Significant unstable or uncontrolled medical condition that may interfere with a subject's participation in the study.
  21. Other severe, acute or chronic, medical or psychiatric condition(s) or laboratory abnormality that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  22. Currently participating in another clinical trial or has done so in the past 30 days.
  23. Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson & Johnson (J&J) subsidiaries, contractors of J&J, and the families of each).

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


Locations
Canada, British Columbia
The Medical Arts Health Research Group
Kelowna, British Columbia, Canada, V1Y 4N7
Mission Hills Urgent Care Walk in Clinic
Mission, British Columbia, Canada, V2V 0C8
James Lai, MD, Inc
Vancouver, British Columbia, Canada
Canada, Ontario
Dawson Road Family Medical Clinic
Guelph, Ontario, Canada, N1H 1B1
Sunningdale Health and Wellness Centre
London, Ontario, Canada, N6G 4W3
Bluewater Clinical Research Group, Inc.
Sarnia, Ontario, Canada, N7T 4X3
NEOMO Research
Sudbury, Ontario, Canada, P3E 6C3
Canadian Phase Onward, Inc.
Toronto, Ontario, Canada, M3J 2C5
PrimeHealth Clinical Research
Toronto, Ontario, Canada, M4S 1Y2
Canada, Quebec
Diex Recherche
Sherbrooke, Quebec, Canada, J1H 1Z1
Diex Recherche
Victoriaville, Quebec, Canada, G6P 6P6
Sponsors and Collaborators
Johnson & Johnson Consumer Inc. (J&JCI)
Investigators
Study Director: Michael Morris Johnson and Johnson Consumer, Inc

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: April 26, 2018
Last Verified: April 2018
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