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
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Post-nasal Drip
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Rhinorrhea
• Seasonal Allergic Rhinitis

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