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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00816972

Enrollment

540

Registered

2009-01-06

Start date

2005-04-30

Completion date

2005-06-30

Last updated

2022-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-nasal Drip, Rhinorrhea, Seasonal Allergic Rhinitis

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.

Interventions

DRUGDesloratadine 2.5 mg

Desloratadine 2.5 mg BID

DRUGOxybutynin 2.5 mg

Oxybutynin 2.5 mg BID

DRUGPlacebo for Desloratadine 2.5 mg

Placebo BID

DRUGPlacebo for Oxybutynin 2.5 mg

Placebo BID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Anterior rhinorrhea averaged over Days 1 to 8	Days 1 to 8

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026