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NCT00816972 Clinical Trial

Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)

Seasonal Allergic Rhinitis Clinical Trial

Official title:
Pilot Efficacy and Safety Field Trial of Desloratadine Administered Concomitantly With Oxybutynin, in Subjects With Seasonal Allergic Rhinitis and Post-Nasal Drip

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00816972
Other study ID # P04258
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2005
Est. completion date June 2005

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 desloratadine twice a day, oxybutynin twice a day, desloratadine plus lower-dose oxybutynin twice a day, desloratadine plus higher-dose oxybutynin twice a day, or placebo for 7 days.

Recruitment information / eligibility
Status Completed
Enrollment 540
Est. completion date June 2005
Est. primary completion date June 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 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 Criteria: 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Desloratadine 2.5 mg
Desloratadine 2.5 mg BID
• Oxybutynin 2.5 mg
Oxybutynin 2.5 mg BID
• Placebo for Desloratadine 2.5 mg
Placebo BID
• Placebo for Oxybutynin 2.5 mg
Placebo BID

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in mean daily AM/PM Prior post-nasal drip scores averaged over the entire treatment period Days 1 to 7 +/- 2 days
Secondary Anterior rhinorrhea averaged over Days 1 to 8 Days 1 to 8
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