PIER: Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold
Sponsor
Johnson & Johnson Consumer Inc. (J&JCI) (Industry)
Overall Status
Terminated
CT.gov ID
NCT03339726
Collaborator
(none)
193
11
3
4.5
17.5
3.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
193 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Nov 30, 2017
Actual Primary Completion Date
:
Apr 16, 2018
Actual Study Completion Date
:
Apr 16, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: New Formulation Phenylephrine HCl
|
Drug: New Formulation Phenylephrine HCl
2 doses of one tablet 12 hours apart
|
| Active Comparator: Marketed Phenylephrine HCl
|
Drug: Marketed Phenylephrine HCl
4 doses of one capsule 4 hours apart
|
| Placebo Comparator: Placebo
|
Drug: Placebo
4 doses of placebo capsule and tablet taken 4 hours apart
|
Outcome Measures
Primary Outcome Measures
- Mean Change From Baseline in the Nasal Congestion Severity Score [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.
Secondary Outcome Measures
- Average Change From Baseline in the Nasal Congestion Severity Score [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [0-4 hours]
Change from baseline in Sinus Pressure/Tenderness Scores at 4 hours.
- Change From Baseline in Sinus Pressure/Tenderness Scores [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 [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 [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 [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 [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
-
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Medical Arts Health Research Group | Kelowna | British Columbia | Canada | V1Y 4N7 |
| 2 | Mission Hills Urgent Care Walk in Clinic | Mission | British Columbia | Canada | V2V 0C8 |
| 3 | James Lai, MD, Inc | Vancouver | British Columbia | Canada | |
| 4 | Dawson Road Family Medical Clinic | Guelph | Ontario | Canada | N1H 1B1 |
| 5 | Sunningdale Health and Wellness Centre | London | Ontario | Canada | N6G 4W3 |
| 6 | Bluewater Clinical Research Group, Inc. | Sarnia | Ontario | Canada | N7T 4X3 |
| 7 | NEOMO Research | Sudbury | Ontario | Canada | P3E 6C3 |
| 8 | Canadian Phase Onward, Inc. | Toronto | Ontario | Canada | M3J 2C5 |
| 9 | PrimeHealth Clinical Research | Toronto | Ontario | Canada | M4S 1Y2 |
| 10 | Diex Recherche | Sherbrooke | Quebec | Canada | J1H 1Z1 |
| 11 | Diex Recherche | Victoriaville | Quebec | Canada | G6P 6P6 |
Sponsors and Collaborators
- Johnson & Johnson Consumer Inc. (J&JCI)
Investigators
- Study Director: Steve Sacavage, Johnson and Johnson Consumer, Inc
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Johnson & Johnson Consumer Inc. (J&JCI)
ClinicalTrials.gov Identifier:
NCT03339726
Other Study ID Numbers:
- CO-170302131230-URCT
First Posted:
Nov 13, 2017
Last Update Posted:
Jun 4, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Period Title: Overall Study | |||
| STARTED | 64 | 66 | 63 |
| COMPLETED | 63 | 65 | 63 |
| NOT COMPLETED | 1 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Placebo | PE-IR | PE-ER | Total |
|---|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. | Total of all reporting groups |
| Overall Participants | 64 | 66 | 63 | 193 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
44.7
(14.60)
|
43.4
(14.71)
|
46.4
(15.44)
|
44.8
(14.89)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
47
73.4%
|
37
56.1%
|
38
60.3%
|
122
63.2%
|
| Male |
17
26.6%
|
29
43.9%
|
25
39.7%
|
71
36.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
5
7.8%
|
2
3%
|
3
4.8%
|
10
5.2%
|
| Not Hispanic or Latino |
59
92.2%
|
64
97%
|
60
95.2%
|
183
94.8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
2
3.1%
|
3
4.5%
|
1
1.6%
|
6
3.1%
|
| Asian |
7
10.9%
|
11
16.7%
|
7
11.1%
|
25
13%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
3.1%
|
3
4.5%
|
0
0%
|
5
2.6%
|
| White |
50
78.1%
|
48
72.7%
|
53
84.1%
|
151
78.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
3
4.7%
|
1
1.5%
|
2
3.2%
|
6
3.1%
|
| Region of Enrollment (Count of Participants) | ||||
| CAN |
64
100%
|
66
100%
|
63
100%
|
193
100%
|
Outcome Measures
| Title | Mean Change From Baseline in the Nasal Congestion Severity Score |
|---|---|
| Description | 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. |
| Time Frame | 0-12 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
1.80
(0.156)
|
2.03
(0.154)
|
1.93
(0.158)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.300 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.205 to 0.662 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.220 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.569 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.311 to 0.564 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.222 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.645 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.537 to 0.333 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.220 |
|
| Estimation Comments | ||
| Title | Average Change From Baseline in the Nasal Congestion Severity Score |
|---|---|
| Description | 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. |
| Time Frame | 0-12 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
2.14
(0.185)
|
2.39
(0.182)
|
2.16
(0.187)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.346 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.25 | |
| Confidence Interval |
(2-Sided) 95% -0.267 to 0.759 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.260 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.938 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.498 to 0.539 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.263 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.389 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.741 to 0.289 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.261 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Nasal Congestion Severity Score |
|---|---|
| Description | Change from baseline in the Nasal Congestion Severity Score at 2 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Time Frame | 0-2 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
1.12
(0.163)
|
1.24
(0.161)
|
1.52
(0.165)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.607 |
| Comments | ||
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.33 to 0.57 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.230 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.085 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.40 | |
| Confidence Interval |
(2-Sided) 95% -0.06 to 0.86 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.232 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.220 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.28 | |
| Confidence Interval |
(2-Sided) 95% -0.17 to 0.74 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.230 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Nasal Congestion Severity Score |
|---|---|
| Description | Change from baseline in the Nasal Congestion Severity Score at 4 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Time Frame | 0-4 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
1.69
(0.193)
|
1.82
(0.190)
|
1.71
(0.194)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.633 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.40 to 0.66 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.271 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.952 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.52 to 0.56 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.273 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.678 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.65 to 0.42 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.272 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Nasal Congestion Severity Score |
|---|---|
| Description | Change from baseline in the Nasal Congestion Severity Score at 6 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Time Frame | 0-6 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
1.58
(0.178)
|
1.97
(0.176)
|
1.86
(0.180)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.126 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.38 | |
| Confidence Interval |
(2-Sided) 95% -0.11 to 0.88 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.250 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.270 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.28 | |
| Confidence Interval |
(2-Sided) 95% -0.22 to 0.78 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.253 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.676 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.60 to 0.39 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.251 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Nasal Congestion Severity Score |
|---|---|
| Description | Change from baseline in the Nasal Congestion Severity Score at 8 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Time Frame | 0-8 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
2.00
(0.188)
|
2.22
(0.185)
|
1.99
(0.189)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.421 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.21 | |
| Confidence Interval |
(2-Sided) 95% -0.31 to 0.73 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.264 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.970 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.54 to 0.52 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.266 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.401 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.74 to 0.30 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.265 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Nasal Congestion Severity Score |
|---|---|
| Description | Change from baseline in the Nasal Congestion Severity Score at 10 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Time Frame | 0-10 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
2.14
(0.193)
|
2.45
(0.191)
|
2.18
(0.195)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.257 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.31 | |
| Confidence Interval |
(2-Sided) 95% -0.23 to 0.85 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.272 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.877 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to 0.58 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.275 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.329 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.80 to 0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.273 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Nasal Congestion Severity Score |
|---|---|
| Description | Change from baseline in the Nasal Congestion Severity Score at 12 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Time Frame | 0-12 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
2.28
(0.212)
|
2.50
(0.209)
|
2.31
(0.214)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.469 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.37 to 0.80 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.298 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.924 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.57 to 0.62 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.301 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.532 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.78 to 0.40 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.299 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Nasal Congestion Severity Score |
|---|---|
| Description | Change from baseline in the Nasal Congestion Severity Score at 24 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Time Frame | 0-24 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
2.78
(0.220)
|
2.61
(0.217)
|
2.52
(0.222)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.579 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.78 to 0.44 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.309 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.394 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.88 to 0.35 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.312 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.760 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANOVA | |
| Comments | Treatment and baseline nasal congestion score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.09 | |
| Confidence Interval |
(2-Sided) 95% -0.71 to 0.52 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.310 |
|
| Estimation Comments | ||
| Title | Average Change From Baseline in Sinus Pressure/Tenderness Scores |
|---|---|
| Description | 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. |
| Time Frame | 0-12 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
1.67
(0.155)
|
1.78
(0.152)
|
1.74
(0.156)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.616 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.320 to 0.539 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.218 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.734 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.07 | |
| Confidence Interval |
(2-Sided) 95% -0.359 to 0.508 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.220 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.874 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.465 to 0.395 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.218 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Sinus Pressure/Tenderness Scores |
|---|---|
| Description | Change from baseline in Sinus Pressure/Tenderness Scores at 2 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Time Frame | 0-2 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
1.10
(0.163)
|
1.03
(0.161)
|
1.30
(0.164)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.750 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.07 | |
| Confidence Interval |
(2-Sided) 95% -0.53 to 0.38 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.230 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.390 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.20 | |
| Confidence Interval |
(2-Sided) 95% -0.26 to 0.66 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.232 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.236 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.18 to 0.73 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.230 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Sinus Pressure/Tenderness Scores |
|---|---|
| Description | Change from baseline in Sinus Pressure/Tenderness Scores at 4 hours. |
| Time Frame | 0-4 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
1.54
(0.190)
|
1.43
(0.187)
|
1.48
(0.191)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.707 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.63 to 0.43 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.267 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.839 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.59 to 0.48 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.269 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.864 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.48 to 0.57 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.267 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Sinus Pressure/Tenderness Scores |
|---|---|
| Description | Change from baseline in Sinus Pressure/Tenderness Scores at 6 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Time Frame | 0-6 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
1.62
(0.181)
|
1.69
(0.179)
|
1.75
(0.182)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.794 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.07 | |
| Confidence Interval |
(2-Sided) 95% -0.44 to 0.57 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.255 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.628 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.38 to 0.63 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.257 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.820 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.45 to 0.56 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.255 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Sinus Pressure/Tenderness Scores |
|---|---|
| Description | Change from baseline in Sinus Pressure/Tenderness Scores at 8 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Time Frame | 0-8 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
1.69
(0.189)
|
1.95
(0.186)
|
1.82
(0.190)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.330 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.26 | |
| Confidence Interval |
(2-Sided) 95% -0.27 to 0.79 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.266 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.631 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.40 to 0.66 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.269 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.625 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.66 to 0.40 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.266 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Sinus Pressure/Tenderness Scores |
|---|---|
| Description | Change from baseline in Sinus Pressure/Tenderness Scores at 10 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Time Frame | 0-10 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on scale] |
1.91
(0.196)
|
2.23
(0.193)
|
1.96
(0.197)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.240 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.32 | |
| Confidence Interval |
(2-Sided) 95% -0.22 to 0.87 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.275 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.865 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to 0.60 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.278 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.316 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.28 | |
| Confidence Interval |
(2-Sided) 95% -0.82 to 0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.275 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Sinus Pressure/Tenderness Scores |
|---|---|
| Description | Change from baseline in Sinus Pressure/Tenderness Scores at 12 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Time Frame | 0-12 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
2.15
(0.202)
|
2.32
(0.199)
|
2.15
(0.203)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.529 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.38 to 0.74 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.284 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.997 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.00 | |
| Confidence Interval |
(2-Sided) 95% -0.56 to 0.57 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.287 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.532 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.74 to 0.38 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.285 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Sinus Pressure/Tenderness Scores |
|---|---|
| Description | Change from baseline in Sinus Pressure/Tenderness Scores at 24 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Time Frame | 0-24 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Placebo | PE-IR | PE-ER |
|---|---|---|---|
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. |
| Measure Participants | 64 | 66 | 63 |
| Mean (Standard Error) [units on a scale] |
2.61
(0.220)
|
2.39
(0.216)
|
2.23
(0.221)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-IR |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.468 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.83 to 0.38 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.309 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.218 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.39 | |
| Confidence Interval |
(2-Sided) 95% -1.00 to 0.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.312 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PE-IR, PE-ER |
|---|---|---|
| Comments | The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.604 |
| Comments | The significance threshold level was 0.05 (two sided). | |
| Method | ANCOVA | |
| Comments | Treatment and baseline sinus pressure/tenderness score were factors. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.77 to 0.45 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.309 |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Within three days for nonserious adverse events, +30 days after the participant's last dose or exposure to the investigational product for serious adverse events. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | AEs were systematically collected during the study and at the follow-up visit at Day 2 (+/-1 day). Spontaneously reported AEs collected during the study were also recorded. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. | |||||
| Arm/Group Title | Placebo | PE-IR | PE-ER | |||
| Arm/Group Description | One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily. | One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily. | 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. | |||
All Cause Mortality |
||||||
| Placebo | PE-IR | PE-ER | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/64 (0%) | 0/66 (0%) | 0/63 (0%) | |||
Serious Adverse Events |
||||||
| Placebo | PE-IR | PE-ER | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/64 (0%) | 0/66 (0%) | 0/63 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Placebo | PE-IR | PE-ER | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/64 (0%) | 0/66 (0%) | 0/63 (0%) | |||
Limitations/Caveats
An interim statistical analysis was conducted after the study failed to meet planned enrollment in the 2017-2018 cold season. The study was subsequently cancelled and enrollment was discontinued. Analysis of the 193 enrolled subjects was conducted.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Steven Sacavage, PharmD, Associate Director, Global Pain & Allergy Clinical Research |
|---|---|
| Organization | JNJWorldwide |
| Phone | 215 273-8568 ext 8568 |
| ssacavag@its.jnj.com |
Responsible Party:
Johnson & Johnson Consumer Inc. (J&JCI)
ClinicalTrials.gov Identifier:
NCT03339726
Other Study ID Numbers:
- CO-170302131230-URCT
First Posted:
Nov 13, 2017
Last Update Posted:
Jun 4, 2019
Last Verified:
Jun 1, 2019