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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-nasal Drip; Seasonal Allergic Rhinitis; Rhinorrhea

Intervention: Desloratadine 2.5 mg (Drug); Oxybutynin 2.5 mg (Drug); Placebo for Desloratadine 2.5 mg (Drug); Placebo for Oxybutynin 2.5 mg (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from baseline in mean daily AM/PM Prior post-nasal drip scores averaged over the entire treatment period

Secondary outcome: Anterior rhinorrhea averaged over Days 1 to 8


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Additional Information

Starting date: April 2005
Last updated: July 21, 2015

Page last updated: August 23, 2015

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