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