Status:
COMPLETED
Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)
Lead Sponsor:
Organon and Co
Conditions:
Post-nasal Drip
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was a 1-week study of desloratadine (DL) plus oxybutynin (OXY) at two dose levels in the treatment of post-nasal drip in participants with seasonal allergic rhinitis. Participants received either...
Eligibility Criteria
Inclusion
- Subjects must:
- be \>=18 years of age,
- be free of any clinically significant disease that would interfere with study, other than seasonal allergic rhinitis (SAR),
- have a documented diagnosis of SAR for \>=2 years,
- have had a positive skin-prick test,
- be sufficiently symptomatic at the Screening visit,
- for the 3 calendar days immediately prior to baseline visit, plus the AM of the baseline visit, the seven twice-daily run-in diary PRIOR total nasal symptom scores must have totaled \>=42, the Total Non-Nasal Symptoms score must have totaled \>=28, and the total Post Nasal Drip score must have totaled \>=14,
- be in general good health.
Exclusion
- Subjects who have:
- certain medical conditions or medical histories,
- allergies to any of the components in any of the study medications,
- nasal structure abnormalities,
- dependency to nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids,
- used any investigational drug use in past 30 days,
- received immunotherapy (desensitization)
- are pregnant
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00816972
Start Date
April 1 2005
End Date
June 1 2005
Last Update
February 16 2022
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