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Completed

NCT Number: NCT00816972

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

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.

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Key information

Conditions

Post-nasal Drip Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Rhinorrhea Seasonal Allergic Rhinitis Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desloratadine 2.5 mg

Drug

Desloratadine 2.5 mg BID

Other names: SCH 034117, Clarinex

Oxybutynin 2.5 mg

Drug

Oxybutynin 2.5 mg BID

Other names: Ditropan

Placebo for Desloratadine 2.5 mg

Drug

Placebo BID

Placebo for Oxybutynin 2.5 mg

Drug

Placebo BID

Primary outcomes

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

    Time frame: Days 1 to 7 +/- 2 days

Secondary outcomes

  1. Anterior rhinorrhea averaged over Days 1 to 8

    Time frame: Days 1 to 8

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Jan 6, 2009
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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