Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)
NCT ID: NCT00816972
Last Updated: 2022-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
540 participants
INTERVENTIONAL
2005-04-30
2005-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DL 2.5 mg
Desloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days
Desloratadine 2.5 mg
Desloratadine 2.5 mg BID
Placebo for Oxybutynin 2.5 mg
Placebo BID
OXY 5 mg
Placebo for Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days
Oxybutynin 2.5 mg
Oxybutynin 2.5 mg BID
Placebo for Desloratadine 2.5 mg
Placebo BID
DL 2.5 mg + OXY 2.5 mg
Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days
Desloratadine 2.5 mg
Desloratadine 2.5 mg BID
Oxybutynin 2.5 mg
Oxybutynin 2.5 mg BID
Placebo for Oxybutynin 2.5 mg
Placebo BID
DL 2.5 mg + OXY 5 mg
Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days
Desloratadine 2.5 mg
Desloratadine 2.5 mg BID
Oxybutynin 2.5 mg
Oxybutynin 2.5 mg BID
Placebo
Placebo for Desloratadine 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days
Placebo for Desloratadine 2.5 mg
Placebo BID
Placebo for Oxybutynin 2.5 mg
Placebo BID
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Other Identifiers
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P04258
Identifier Type: -
Identifier Source: org_study_id
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