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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):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

November 8, 2017
November 13, 2017
December 6, 2017
November 30, 2017
March 30, 2018   (Final data collection date for primary outcome measure)
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
Average change from baseline in the nasal congestion severity score (NCSS) [ Time Frame: 0-12 hours ]
Average change from baseline in the nasal congestion severity score (NCSS) over hours 0-12
Complete list of historical versions of study NCT03339726 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-4 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 4 hours.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Average Change from baseline in the NCSS [ Time Frame: 0-12 hours ]
    Average change from baseline in the NCSS averaged over hours 8-12
  • Change from baseline in the NCSS [ Time Frame: 0-2 hours ]
    Change from baseline in the NCSS at 2 hours
  • Change from baseline in the NCSS [ Time Frame: 0-4 hours ]
    Change from baseline in the NCSS at 4 hours.
  • Change from baseline in the NCSS [ Time Frame: 0-6 hours ]
    Change from baseline in the NCSS at 6 hours.
  • Change from baseline in the NCSS [ Time Frame: 0-8 hours ]
    Change from baseline in the NCSS at 8 hours.
  • Change from baseline in the NCSS [ Time Frame: 0-10 hours ]
    Change from baseline in the NCSS at 10 hours.
  • Change from baseline in the NCSS [ Time Frame: 0-12 hours ]
    Change from baseline in the NCSS at 12 hours.
  • Change from baseline in the NCSS [ Time Frame: 0-24 hours ]
    Change from baseline in the NCSS at 24 hours.
  • 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.
  • Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-2 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 2 hours.
  • Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-4 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 4 hours.
  • Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-6 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 6 hours.
  • Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-8 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 8 hours.
  • Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-10 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 10 hours.
  • Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-12 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 12 hours.
  • Change from baseline in Sinus Pressure/Tenderness Scores [ Time Frame: 0-24 hours ]
    Change from baseline in Sinus Pressure/Tenderness Scores at 24 hours.
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Common Cold
  • Drug: New Formulation Phenylephrine HCl
    2 doses of one tablet 12 hours apart
  • Drug: Marketed Phenylephrine HCl
    4 doses of one capsule 4 hours apart
  • Drug: Placebo
    4 doses of placebo capsule and tablet taken 4 hours apart
  • Experimental: New Formulation Phenylephrine HCl
    Intervention: Drug: New Formulation Phenylephrine HCl
  • Active Comparator: Marketed Phenylephrine HCl
    Intervention: Drug: Marketed Phenylephrine HCl
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
Same as current
April 3, 2018
March 30, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Michael Morris 441628827036 mmorris6@its.jnj.com
Contact: Janice Solla 215-273-7571 jsolla1@its.jnj.com
Canada
 
 
NCT03339726
CO-170302131230-URCT
No
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
Plan to Share IPD: Undecided
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )
Johnson & Johnson Consumer Inc. (J&JCI)
Not Provided
Study Director: Michael Morris Johnson and Johnson Consumer, Inc
Johnson & Johnson Consumer and Personal Products Worldwide
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP