Randomized, Double-blind, Placebo-Controlled, Efficacy St... | NCT03339726

Label	Type	Intervention Names
New Formulation Phenylephrine HCl	Experimental	Drug: New Formulation Phenylephrine HCl
Marketed Phenylephrine HCl	Active Comparator	Drug: Marketed Phenylephrine HCl
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
New Formulation Phenylephrine HCl	Drug	2 doses of one tablet 12 hours apart	New Formulation Phenylephrine HCl

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

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

Eligibility Module

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:
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.
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
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.
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).

Name	Affiliation	Role
Steve Sacavage	Johnson and Johnson Consumer, Inc	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
The Medical Arts Health Research Group		Kelowna	British Columbia	V1Y 4N7	Canada
Mission Hills Urgent Care Walk in Clinic

ID	Title	Description
FG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
FG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 14, 2018	Apr 15, 2019

ID	Title	Description
BG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
BG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
BG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00064 BG00166 BG00263 BG003193

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-12 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units	Counts
Participants	OG00064 OG00166 OG00263

Title

Denominators

Categories

Title	Measurements
	OG0001.80± 0.156 OG0012.03± 0.154 OG0021.93± 0.158

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.	ANOVA	Treatment and baseline nasal congestion score were factors.	0.300	The significance threshold level was 0.05 (two sided).	Mean Difference (Final Values)	0.23	Standard Error of the Mean	0.220	2-Sided	95	-0.205	0.662					Superiority

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-12 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-2 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-4 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-6 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-8 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-10 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-12 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-24 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-12 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-2 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units	Counts

Secondary

Change From Baseline in Sinus Pressure/Tenderness Scores

Change from baseline in Sinus Pressure/Tenderness Scores at 4 hours.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-4 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units	Counts

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-6 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units	Counts

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-8 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units	Counts

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on scale

0-10 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units	Counts

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-12 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units

Secondary

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.

Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.

Posted

Mean

Standard Error

units on a scale

0-24 hours

ID	Title	Description
OG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
OG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
OG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.

Units

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Placebo	One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.	64	64	64
EG001	PE-IR	One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.	66	66	66
EG002	PE-ER	One Phenylephrine HCl Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily AND One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Twice Daily.	63	63	63