Trial Outcomes & Findings for The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579) (NCT NCT00276016)
NCT ID: NCT00276016
Last Updated: 2022-02-09
Results Overview
To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing. The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
39 participants
Primary outcome timeframe
Baseline to endpoint (6 hour period)
Results posted on
2022-02-09
Participant Flow
1 subject discontinued for reasons unrelated to treatment with study drug after the first dose (Intervention 1) of study drug Pseudoephedrine(PSE)
Participant milestones
| Measure |
Phenylephrine, Pseudoephedrine, Placebo
Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules
|
Pseudoephedrine, Placebo, Phenylephrine
Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
|
Placebo, Phenylephrine, Pseudoephedrine
Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
|
Phenylephrine, Placebo, Pseudoephedrine
Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
|
Pseudoephedrine, Phenylephrine, Placebo
Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release
12 mg capsules for oral administration. Placebo: Placebo capsules.
|
Placebo, Pseudoephedrine, Phenylephrine
Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
|
|---|---|---|---|---|---|---|
|
Intervention 1
STARTED
|
7
|
7
|
7
|
6
|
6
|
6
|
|
Intervention 1
COMPLETED
|
7
|
6
|
7
|
6
|
6
|
6
|
|
Intervention 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Wash Out 1
STARTED
|
7
|
6
|
7
|
6
|
6
|
6
|
|
Wash Out 1
COMPLETED
|
7
|
6
|
7
|
6
|
6
|
6
|
|
Wash Out 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention 2
STARTED
|
7
|
6
|
7
|
6
|
6
|
6
|
|
Intervention 2
COMPLETED
|
7
|
6
|
7
|
6
|
6
|
6
|
|
Intervention 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Wash Out 2
STARTED
|
7
|
6
|
7
|
6
|
6
|
6
|
|
Wash Out 2
COMPLETED
|
7
|
6
|
7
|
6
|
6
|
6
|
|
Wash Out 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention 3
STARTED
|
7
|
6
|
7
|
6
|
6
|
6
|
|
Intervention 3
COMPLETED
|
7
|
6
|
7
|
6
|
6
|
6
|
|
Intervention 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phenylephrine, Pseudoephedrine, Placebo
Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules
|
Pseudoephedrine, Placebo, Phenylephrine
Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
|
Placebo, Phenylephrine, Pseudoephedrine
Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
|
Phenylephrine, Placebo, Pseudoephedrine
Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
|
Pseudoephedrine, Phenylephrine, Placebo
Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release
12 mg capsules for oral administration. Placebo: Placebo capsules.
|
Placebo, Pseudoephedrine, Phenylephrine
Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
|
|---|---|---|---|---|---|---|
|
Intervention 1
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)
Baseline characteristics by cohort
| Measure |
Phenylephrine, Pseudoephedrine, Placebo
n=7 Participants
Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules
|
Pseudoephedrine, Placebo, Phenylephrine
n=7 Participants
Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
|
Placebo, Phenylephrine, Pseudoephedrine
n=7 Participants
Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
|
Phenylephrine, Placebo, Pseudoephedrine
n=6 Participants
Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
|
Pseudoephedrine, Phenylephrine, Placebo
n=6 Participants
Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release
12 mg capsules for oral administration. Placebo: Placebo capsules.
|
Placebo, Pseudoephedrine, Phenylephrine
n=6 Participants
Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
|
27.9 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
27.9 years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
24.9 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
26.3 years
STANDARD_DEVIATION 1.6 • n=4 Participants
|
28.0 years
STANDARD_DEVIATION 7.1 • n=21 Participants
|
27.3 years
STANDARD_DEVIATION 3.3 • n=8 Participants
|
27.0 years
STANDARD_DEVIATION 5.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline to endpoint (6 hour period)To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing. The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results.
Outcome measures
| Measure |
Placebo
n=38 Participants
|
Phenylephrine
n=38 Participants
|
|---|---|---|
|
The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo
Baseline score
|
2.20 Units on a scale
Standard Deviation 0.36
|
2.20 Units on a scale
Standard Deviation 0.36
|
|
The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo
Change from Baseline to Endpoint Score
|
-0.12 Units on a scale
Standard Deviation 0.44
|
-0.18 Units on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Baseline to endpoint (6 hour period)To estimate the effect of a pseudoephedrine (PSE) 60 mg immediate release tablet on nasal congestion over a 6-hour observation period relative to placebo The values for the nasal congestion score scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results.
Outcome measures
| Measure |
Placebo
n=39 Participants
|
Phenylephrine
n=38 Participants
|
|---|---|---|
|
The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.
Baseline
|
2.26 Units on a scale
Standard Deviation 0.36
|
2.20 Units on a scale
Standard Deviation 0.36
|
|
The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.
Endpoint
|
-0.47 Units on a scale
Standard Deviation 0.44
|
-0.12 Units on a scale
Standard Deviation 0.44
|
Adverse Events
Phenylephrine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pseudoephedrine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60