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

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).