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

Organon

Status and phase: Completed; Phase 2

Conditions: Rhinorrhea; Seasonal Allergic Rhinitis; Post-nasal Drip

Treatments: Drug: Desloratadine 2.5 mg; Drug: Placebo for Oxybutynin 2.5 mg; Drug: Placebo for Desloratadine 2.5 mg; Drug: Oxybutynin 2.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00816972

P04258

Details and patient eligibility

About

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.

Enrollment: 540 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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540 participants in 5 patient groups, including a placebo group

DL 2.5 mg

Active Comparator group

Description:

Desloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days

Treatment:

Drug: Desloratadine 2.5 mg

Drug: Placebo for Oxybutynin 2.5 mg

OXY 5 mg

Active Comparator group

Description:

Placebo for Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days

Treatment:

Drug: Oxybutynin 2.5 mg

Drug: Placebo for Desloratadine 2.5 mg

DL 2.5 mg + OXY 2.5 mg

Experimental group

Description:

Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days

Treatment:

Drug: Oxybutynin 2.5 mg

Drug: Desloratadine 2.5 mg

Drug: Placebo for Oxybutynin 2.5 mg

DL 2.5 mg + OXY 5 mg

Experimental group

Description:

Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days

Treatment:

Drug: Oxybutynin 2.5 mg

Drug: Desloratadine 2.5 mg

Placebo

Placebo Comparator group

Description:

Placebo for Desloratadine 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days

Treatment:

Drug: Placebo for Desloratadine 2.5 mg

Drug: Placebo for Oxybutynin 2.5 mg