Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold
Condition: Common Cold
MeSH terms: Common Cold
Intervention: New Formulation Phenylephrine HCl; Marketed Phenylephrine HCl; Placebo
Intervention description: 2 doses of one tablet 12 hours apart; 4 doses of one capsule 4 hours apart; 4 doses of placebo capsule and tablet taken 4 hours apart
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 193.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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).