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Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01413958
First received: August 9, 2011
Last updated: December 18, 2012
Last verified: November 2012
History of Changes
Results First Received: October 8, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Seasonal Allergic Rhinitis
Interventions: Drug: Phenylephrine
Drug: Placebo
Drug: Loratadine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
29 centers in the United States; Study Period: August 2011 to October 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Phenylephrine Phenylephrine hydrochloride, 30 mg extended-release tablets, one tablet every 12 hours for 7 days
Placebo Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days

Participant Flow:   Overall Study
    Phenylephrine     Placebo  
STARTED     288     287  
COMPLETED     288     286  
NOT COMPLETED     0     1  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Phenylephrine Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Placebo Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Total Total of all reporting groups

Baseline Measures
    Phenylephrine     Placebo     Total  
Number of Participants  
[units: participants]
 		  288     287     575  
Age  
[units: years]
Mean ± Standard Deviation 		  40.1  ± 11.64     40.1  ± 11.62     40.1  ± 11.62  
Gender  
[units: participants]
 		     
Female     176     177     353  
Male     112     110     222  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Daily Reflective Nasal Congestion Score   [ Time Frame: Baseline and Days 1-7 ]
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2.  Secondary:   Mean Change From Baseline in the Morning Reflective Symptom Assessment Score   [ Time Frame: Baseline and Days 1-7 ]
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3.  Secondary:   Mean Change From Baseline in the Evening Reflective Symptom Assessment Score   [ Time Frame: Baseline and Days 1-7 ]
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4.  Secondary:   Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score   [ Time Frame: Baseline and Days 1-7 ]
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5.  Secondary:   Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day   [ Time Frame: Baseline and Day 1, 2, 3, 4, 5, 6, and 7 ]
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6.  Secondary:   Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day   [ Time Frame: Baseline and Day 1, 2, 3, 4, 5, 6, 7 ]
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7.  Secondary:   Time to Maximal Phenylephrine Effect   [ Time Frame: Baseline up to Day 7 ]
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8.  Secondary:   Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score   [ Time Frame: Baseline and Day 7 ]
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9.  Secondary:   Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score   [ Time Frame: Baseline and Days 1-7 ]
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10.  Secondary:   Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period.   [ Time Frame: Baseline and Day 2, 3, 4, 5, 6, and 7 ]
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11.  Secondary:   Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period   [ Time Frame: Baseline and Day 1, 2, 3, 4, 5, 6, and 7 ]
  Show Outcome Measure 11

12.  Secondary:   Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period   [ Time Frame: Baseline and Day 2, 3, 4, 5, 6, and 7 ]
  Show Outcome Measure 12

13.  Secondary:   Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period.   [ Time Frame: Baseline and Day 1, 2, 3, 4, 5, 6, and 7 ]
  Show Outcome Measure 13

14.  Secondary:   Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ)   [ Time Frame: Up to Day 8 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked 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.
unchecked 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01413958     History of Changes
Other Study ID Numbers: P08498, CL2011-06
Study First Received: August 9, 2011
Results First Received: October 8, 2012
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration