Trial Outcomes & Findings for Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold (NCT NCT03339726)
NCT ID: NCT03339726
Last Updated: 2019-06-04
Results Overview
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.
TERMINATED
PHASE2
193 participants
0-12 hours
2019-06-04
Participant Flow
Participant milestones
| Measure |
Placebo
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
66
|
63
|
|
Overall Study
COMPLETED
|
63
|
65
|
63
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold
Baseline characteristics by cohort
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 14.60 • n=5 Participants
|
43.4 years
STANDARD_DEVIATION 14.71 • n=7 Participants
|
46.4 years
STANDARD_DEVIATION 15.44 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 14.89 • n=4 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
183 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
North America · CAN
|
64 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0-12 hoursPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Mean Change From Baseline in the Nasal Congestion Severity Score
|
1.80 units on a scale
Standard Error 0.156
|
2.03 units on a scale
Standard Error 0.154
|
1.93 units on a scale
Standard Error 0.158
|
SECONDARY outcome
Timeframe: 0-12 hoursPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Average Change From Baseline in the Nasal Congestion Severity Score
|
2.14 units on a scale
Standard Error 0.185
|
2.39 units on a scale
Standard Error 0.182
|
2.16 units on a scale
Standard Error 0.187
|
SECONDARY outcome
Timeframe: 0-2 hoursPopulation: 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.
Change from baseline in the Nasal Congestion Severity Score at 2 hours. This is an 8 point scale with 0=None and 7=Severe.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in the Nasal Congestion Severity Score
|
1.12 units on a scale
Standard Error 0.163
|
1.24 units on a scale
Standard Error 0.161
|
1.52 units on a scale
Standard Error 0.165
|
SECONDARY outcome
Timeframe: 0-4 hoursPopulation: 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.
Change from baseline in the Nasal Congestion Severity Score at 4 hours. This is an 8 point scale with 0=None and 7=Severe.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in the Nasal Congestion Severity Score
|
1.69 units on a scale
Standard Error 0.193
|
1.82 units on a scale
Standard Error 0.190
|
1.71 units on a scale
Standard Error 0.194
|
SECONDARY outcome
Timeframe: 0-6 hoursPopulation: 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.
Change from baseline in the Nasal Congestion Severity Score at 6 hours. This is an 8 point scale with 0=None and 7=Severe.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in the Nasal Congestion Severity Score
|
1.58 units on a scale
Standard Error 0.178
|
1.97 units on a scale
Standard Error 0.176
|
1.86 units on a scale
Standard Error 0.180
|
SECONDARY outcome
Timeframe: 0-8 hoursPopulation: 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.
Change from baseline in the Nasal Congestion Severity Score at 8 hours. This is an 8 point scale with 0=None and 7=Severe.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in the Nasal Congestion Severity Score
|
2.00 units on a scale
Standard Error 0.188
|
2.22 units on a scale
Standard Error 0.185
|
1.99 units on a scale
Standard Error 0.189
|
SECONDARY outcome
Timeframe: 0-10 hoursPopulation: 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.
Change from baseline in the Nasal Congestion Severity Score at 10 hours. This is an 8 point scale with 0=None and 7=Severe.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in the Nasal Congestion Severity Score
|
2.14 units on a scale
Standard Error 0.193
|
2.45 units on a scale
Standard Error 0.191
|
2.18 units on a scale
Standard Error 0.195
|
SECONDARY outcome
Timeframe: 0-12 hoursPopulation: 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.
Change from baseline in the Nasal Congestion Severity Score at 12 hours. This is an 8 point scale with 0=None and 7=Severe.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in the Nasal Congestion Severity Score
|
2.28 units on a scale
Standard Error 0.212
|
2.50 units on a scale
Standard Error 0.209
|
2.31 units on a scale
Standard Error 0.214
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: 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.
Change from baseline in the Nasal Congestion Severity Score at 24 hours. This is an 8 point scale with 0=None and 7=Severe.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in the Nasal Congestion Severity Score
|
2.78 units on a scale
Standard Error 0.220
|
2.61 units on a scale
Standard Error 0.217
|
2.52 units on a scale
Standard Error 0.222
|
SECONDARY outcome
Timeframe: 0-12 hoursPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Average Change From Baseline in Sinus Pressure/Tenderness Scores
|
1.67 units on a scale
Standard Error 0.155
|
1.78 units on a scale
Standard Error 0.152
|
1.74 units on a scale
Standard Error 0.156
|
SECONDARY outcome
Timeframe: 0-2 hoursPopulation: 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.
Change from baseline in Sinus Pressure/Tenderness Scores at 2 hours. This is an 8 point scale with 0=None and 7=Severe.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Sinus Pressure/Tenderness Scores
|
1.10 units on a scale
Standard Error 0.163
|
1.03 units on a scale
Standard Error 0.161
|
1.30 units on a scale
Standard Error 0.164
|
SECONDARY outcome
Timeframe: 0-4 hoursPopulation: 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.
Change from baseline in Sinus Pressure/Tenderness Scores at 4 hours.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Sinus Pressure/Tenderness Scores
|
1.54 units on a scale
Standard Error 0.190
|
1.43 units on a scale
Standard Error 0.187
|
1.48 units on a scale
Standard Error 0.191
|
SECONDARY outcome
Timeframe: 0-6 hoursPopulation: 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.
Change from baseline in Sinus Pressure/Tenderness Scores at 6 hours. This is an 8 point scale with 0=None and 7=Severe.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Sinus Pressure/Tenderness Scores
|
1.62 units on a scale
Standard Error 0.181
|
1.69 units on a scale
Standard Error 0.179
|
1.75 units on a scale
Standard Error 0.182
|
SECONDARY outcome
Timeframe: 0-8 hoursPopulation: 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.
Change from baseline in Sinus Pressure/Tenderness Scores at 8 hours. This is an 8 point scale with 0=None and 7=Severe.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Sinus Pressure/Tenderness Scores
|
1.69 units on a scale
Standard Error 0.189
|
1.95 units on a scale
Standard Error 0.186
|
1.82 units on a scale
Standard Error 0.190
|
SECONDARY outcome
Timeframe: 0-10 hoursPopulation: 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.
Change from baseline in Sinus Pressure/Tenderness Scores at 10 hours. This is an 8 point scale with 0=None and 7=Severe.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Sinus Pressure/Tenderness Scores
|
1.91 units on scale
Standard Error 0.196
|
2.23 units on scale
Standard Error 0.193
|
1.96 units on scale
Standard Error 0.197
|
SECONDARY outcome
Timeframe: 0-12 hoursPopulation: 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.
Change from baseline in Sinus Pressure/Tenderness Scores at 12 hours. This is an 8 point scale with 0=None and 7=Severe.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Sinus Pressure/Tenderness Scores
|
2.15 units on a scale
Standard Error 0.202
|
2.32 units on a scale
Standard Error 0.199
|
2.15 units on a scale
Standard Error 0.203
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: 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.
Change from baseline in Sinus Pressure/Tenderness Scores at 24 hours. This is an 8 point scale with 0=None and 7=Severe.
Outcome measures
| Measure |
Placebo
n=64 Participants
One Placebo Extended-Release Tablet + One Placebo Immediate-Release Capsule Taken Orally Four Times Daily.
|
PE-IR
n=66 Participants
One Phenylephrine HCl Immediate-Release Capsule + One Placebo Extended-Release Tablet Taken Orally Four Times Daily.
|
PE-ER
n=63 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Sinus Pressure/Tenderness Scores
|
2.61 units on a scale
Standard Error 0.220
|
2.39 units on a scale
Standard Error 0.216
|
2.23 units on a scale
Standard Error 0.221
|
Adverse Events
Placebo
PE-IR
PE-ER
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Steven Sacavage, PharmD, Associate Director, Global Pain & Allergy Clinical Research
JNJWorldwide
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60