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

Study Overview
=================
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.

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

Conditions
-----------------
Common Cold

Intervention / Treatment
-----------------
* Drug: New Formulation Phenylephrine HCl
* Drug: Marketed Phenylephrine HCl
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Provide a signed and dated informed consent form before any study-related procedures. 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 Have experienced onset of common cold symptoms (per subject report) within 72 hours before study entry consisting of cold symptoms per the following: At Visit 1, at least moderate severity (score ≥ 5, on a scale from 0 = none to 7 = severe) for stuffy/congested nose, and At Visit 1, at least mild (score ≥ 3, on a scale from 0 = none to 7 = severe) for sinus pressure/tenderness, and Within the past 72 hours, two or more of the following symptoms: runny nose, sore or scratchy throat, sneezing, headache, malaise, or cough. 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); 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 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. 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 ). 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. Able to read and understand English and/or French; Exclusion criteria: Currently experiencing nasal congestion due to allergic rhinitis or chronic respiratory disease. 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 Presence of asthma. History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, or chronic sleep apnea. Fever of ≥ 101.0 °F (38.3 °C). 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. Are currently taking, or have taken within two weeks of screening, a monoamine oxidase inhibitor (MAOI). 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. Have a bacterial sinus infection within 2 weeks prior to screening. Use of systemic antibiotics within the past 7 days prior to screening. Known or suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates). Use of marijuana containing substances within the 10 days prior to screening and throughout the study. Positive Urine Drug Screen. Use of alcohol throughout the study. 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. Known sensitivity to the investigational product or any excipients of the drug product. Before the first dose of study medicine, use of oral or intranasal cold, cough, allergy, or analgesic/antipyretic medicines within approximately 12 hours; menthol products, medicated lozenge, humidifier, nasal saline spray or throat spray within approximately 6 hours; herbal/dietary supplements within approximately 12 hours. Have difficulty swallowing tablets/capsules or are unable to swallow whole without crushing, chewing, splitting, or dissolving. Subjects who were previously randomized and received the IP. Significant unstable or uncontrolled medical condition that may interfere with a subject's participation in the study. 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. Currently participating in another clinical trial or has done so in the past 30 days. 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Formulation Phenylephrine HCl<br> | Drug: New Formulation Phenylephrine HCl<br>* 2 doses of one tablet 12 hours apart<br>|
| Active Comparator: Marketed Phenylephrine HCl<br> | Drug: Marketed Phenylephrine HCl<br>* 4 doses of one capsule 4 hours apart<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 4 doses of placebo capsule and tablet taken 4 hours apart<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in the Nasal Congestion Severity Score | 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. | 0-12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change From Baseline in the Nasal Congestion Severity Score | 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. | 0-12 hours | 
| Change From Baseline in the Nasal Congestion Severity Score | Change from baseline in the Nasal Congestion Severity Score at 2 hours. This is an 8 point scale with 0=None and 7=Severe. | 0-2 hours | 
| Change From Baseline in the Nasal Congestion Severity Score | Change from baseline in the Nasal Congestion Severity Score at 4 hours. This is an 8 point scale with 0=None and 7=Severe. | 0-4 hours | 
| Change From Baseline in the Nasal Congestion Severity Score | Change from baseline in the Nasal Congestion Severity Score at 6 hours. This is an 8 point scale with 0=None and 7=Severe. | 0-6 hours | 
| Change From Baseline in the Nasal Congestion Severity Score | Change from baseline in the Nasal Congestion Severity Score at 8 hours. This is an 8 point scale with 0=None and 7=Severe. | 0-8 hours | 
| Change From Baseline in the Nasal Congestion Severity Score | Change from baseline in the Nasal Congestion Severity Score at 10 hours. This is an 8 point scale with 0=None and 7=Severe. | 0-10 hours | 
| Change From Baseline in the Nasal Congestion Severity Score | Change from baseline in the Nasal Congestion Severity Score at 12 hours. This is an 8 point scale with 0=None and 7=Severe. | 0-12 hours | 
| Change From Baseline in the Nasal Congestion Severity Score | Change from baseline in the Nasal Congestion Severity Score at 24 hours. This is an 8 point scale with 0=None and 7=Severe. | 0-24 hours | 
| Average Change From Baseline in Sinus Pressure/Tenderness Scores | 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. | 0-12 hours | 
| Change From Baseline in Sinus Pressure/Tenderness Scores | Change from baseline in Sinus Pressure/Tenderness Scores at 2 hours. This is an 8 point scale with 0=None and 7=Severe. | 0-2 hours | 
| Change From Baseline in Sinus Pressure/Tenderness Scores | Change from baseline in Sinus Pressure/Tenderness Scores at 4 hours. | 0-4 hours | 
| Change From Baseline in Sinus Pressure/Tenderness Scores | Change from baseline in Sinus Pressure/Tenderness Scores at 6 hours. This is an 8 point scale with 0=None and 7=Severe. | 0-6 hours | 
| Change From Baseline in Sinus Pressure/Tenderness Scores | Change from baseline in Sinus Pressure/Tenderness Scores at 8 hours. This is an 8 point scale with 0=None and 7=Severe. | 0-8 hours | 
| Change From Baseline in Sinus Pressure/Tenderness Scores | Change from baseline in Sinus Pressure/Tenderness Scores at 10 hours. This is an 8 point scale with 0=None and 7=Severe. | 0-10 hours | 
| Change From Baseline in Sinus Pressure/Tenderness Scores | Change from baseline in Sinus Pressure/Tenderness Scores at 12 hours. This is an 8 point scale with 0=None and 7=Severe. | 0-12 hours | 
| Change From Baseline in Sinus Pressure/Tenderness Scores | Change from baseline in Sinus Pressure/Tenderness Scores at 24 hours. This is an 8 point scale with 0=None and 7=Severe. | 0-24 hours |