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The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)

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ClinicalTrials.gov Identifier: NCT00276016
Recruitment Status : Completed
First Posted : January 12, 2006
Results First Posted : July 29, 2010
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Rhinitis, Allergic, Seasonal
Interventions Drug: phenylephrine
Drug: pseudoephedrine
Drug: placebo
Enrollment 39
Recruitment Details  
Pre-assignment Details 1 subject discontinued for reasons unrelated to treatment with study drug after the first dose (Intervention 1) of study drug Pseudoephedrine(PSE)
Arm/Group Title Phenylephrine, Pseudoephedrine, Placebo Pseudoephedrine, Placebo, Phenylephrine Placebo, Phenylephrine, Pseudoephedrine Phenylephrine, Placebo, Pseudoephedrine Pseudoephedrine, Phenylephrine, Placebo Placebo, Pseudoephedrine, Phenylephrine
Hide Arm/Group Description Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release

12 mg capsules for oral administration. Placebo: Placebo capsules.

Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
Period Title: Intervention 1
Started 7 7 7 6 6 6
Completed 7 6 7 6 6 6
Not Completed 0 1 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0             0             0
Period Title: Wash Out 1
Started 7 6 7 6 6 6
Completed 7 6 7 6 6 6
Not Completed 0 0 0 0 0 0
Period Title: Intervention 2
Started 7 6 7 6 6 6
Completed 7 6 7 6 6 6
Not Completed 0 0 0 0 0 0
Period Title: Wash Out 2
Started 7 6 7 6 6 6
Completed 7 6 7 6 6 6
Not Completed 0 0 0 0 0 0
Period Title: Intervention 3
Started 7 6 7 6 6 6
Completed 7 6 7 6 6 6
Not Completed 0 0 0 0 0 0
Arm/Group Title Phenylephrine, Pseudoephedrine, Placebo Pseudoephedrine, Placebo, Phenylephrine Placebo, Phenylephrine, Pseudoephedrine Phenylephrine, Placebo, Pseudoephedrine Pseudoephedrine, Phenylephrine, Placebo Placebo, Pseudoephedrine, Phenylephrine Total
Hide Arm/Group Description Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.

Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release

12 mg capsules for oral administration. Placebo: Placebo capsules.

Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration Total of all reporting groups
Overall Number of Baseline Participants 7 7 7 6 6 6 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 7 participants 6 participants 6 participants 6 participants 39 participants
27.9  (9.0) 27.9  (3.3) 24.9  (3.5) 26.3  (1.6) 28.0  (7.1) 27.3  (3.3) 27.0  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 7 participants 6 participants 6 participants 6 participants 39 participants
Female
5
  71.4%
5
  71.4%
4
  57.1%
1
  16.7%
3
  50.0%
5
  83.3%
23
  59.0%
Male
2
  28.6%
2
  28.6%
3
  42.9%
5
  83.3%
3
  50.0%
1
  16.7%
16
  41.0%
1.Primary Outcome
Title The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo
Hide Description

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.

Time Frame Baseline to endpoint (6 hour period)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Phenylephrine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 38 38
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline score 2.20  (0.36) 2.20  (0.36)
Change from Baseline to Endpoint Score -0.12  (0.44) -0.18  (0.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Phenylephrine
Comments For endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.561
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.
Hide Description

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.

Time Frame Baseline to endpoint (6 hour period)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pseudoephedrine Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 39 38
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 2.26  (0.36) 2.20  (0.36)
Endpoint -0.47  (0.44) -0.12  (0.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pseudoephedrine, Placebo
Comments For endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phenylephrine Pseudoephedrine Placebo
Hide Arm/Group Description Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules.
All-Cause Mortality
Phenylephrine Pseudoephedrine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phenylephrine Pseudoephedrine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/39 (0.00%)   0/39 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phenylephrine Pseudoephedrine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/39 (0.00%)   0/39 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00276016     History of Changes
Other Study ID Numbers: P04579
First Submitted: January 11, 2006
First Posted: January 12, 2006
Results First Submitted: April 1, 2010
Results First Posted: July 29, 2010
Last Update Posted: September 28, 2015