Status:
COMPLETED
The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)
Lead Sponsor:
Organon and Co
Conditions:
Rhinitis, Allergic, Seasonal
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover study, conducted at a single site in Austria, outside of the normal grass pollen season. An allergic react...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Skin test positive for the grass pollen allergen used in the chamber at Screening or within the prior 12 months.
- A negative urine pregnancy test at Screening and at monthly intervals for female subjects of childbearing potential.
- The following minimum scores at an evaluation time point during each of the 120-minute screening period challenge sessions:
- Nasal Congestion Score of at least 2 (moderate);
- Total Nasal Symptoms Score of at least 6;
- Total Non-nasal Symptoms Score of at least 2.
- Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluations.
- Exclusion Criteria :
- An upper or lower respiratory tract infection within 4 weeks before Screening.
- Dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, in the opinion of the investigator.
- A known potential for hypersensitivity, allergy, or idiosyncratic reaction to the study drug or excipients.
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00276016
Start Date
January 1 2006
End Date
February 1 2006
Last Update
February 9 2022
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