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

• ClinicalTrials.gov Identifier: NCT03339726
• Recruitment Status: Terminated
• First Posted: November 13, 2017
• Results First Posted: June 4, 2019
• Last Update Posted: June 4, 2019
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Tracking Information

• First Submitted Date: November 8, 2017
• First Posted Date: November 13, 2017
• Results First Submitted Date: April 16, 2019
• Results First Posted Date: June 4, 2019
• Last Update Posted Date: June 4, 2019
• Actual Study Start Date: November 30, 2017
• Actual Primary Completion Date: April 16, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 3, 2019)

Mean 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. Change from baseline in the Nasal Congestion Severity Score averaged over assessments at 2, 4, 6, 8, 10, and 12 hours.

Original Primary Outcome Measures (submitted: November 8, 2017)

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

Current Secondary Outcome Measures (submitted: June 3, 2019)

• 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.

Original Secondary Outcome Measures (submitted: November 8, 2017)

• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Common Cold

Intervention

• 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

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 3, 2019): 193
• Original Estimated Enrollment (submitted: November 8, 2017): 450
• Actual Study Completion Date: April 16, 2018
• Actual Primary Completion Date: April 16, 2018 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03339726
• Other Study ID Numbers: CO-170302131230-URCT
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )
• Original Responsible Party: Same as current
• Current Study Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Steve Sacavage; Johnson and Johnson Consumer, Inc

• PRS Account: Johnson & Johnson Consumer and Personal Products Worldwide
• Verification Date: June 2019