Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)
Phase 2
Completed
- Conditions
- Post-nasal DripRhinorrheaSeasonal Allergic Rhinitis
- Interventions
- Drug: Placebo for Oxybutynin 2.5 mg
- Registration Number
- NCT00816972
- Lead Sponsor
- Organon and Co
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 540
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DL 2.5 mg + OXY 2.5 mg Oxybutynin 2.5 mg Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days OXY 5 mg Oxybutynin 2.5 mg Placebo for Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days DL 2.5 mg Desloratadine 2.5 mg Desloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days DL 2.5 mg + OXY 2.5 mg Desloratadine 2.5 mg Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days DL 2.5 mg + OXY 5 mg Desloratadine 2.5 mg Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days Placebo Placebo for Desloratadine 2.5 mg Placebo for Desloratadine 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days DL 2.5 mg + OXY 2.5 mg Placebo for Oxybutynin 2.5 mg Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days DL 2.5 mg Placebo for Oxybutynin 2.5 mg Desloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days OXY 5 mg Placebo for Desloratadine 2.5 mg Placebo for Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days DL 2.5 mg + OXY 5 mg Oxybutynin 2.5 mg Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days Placebo Placebo for Oxybutynin 2.5 mg Placebo for Desloratadine 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Anterior rhinorrhea averaged over Days 1 to 8 Days 1 to 8