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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00816972
First received: January 5, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

This was a 1-week study to see if desloratadine plus oxybutynin at two dose levels works in treating post-nasal drip in patients with seasonal allergic rhinitis. Subjects 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.


Condition Intervention Phase
Post-Nasal Drip
Seasonal Allergic Rhinitis
Rhinorrhea
Drug: desloratadine
Drug: Oxybutynin
Phase 2

Schering-Plough has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Efficacy and Safety Field Trial of Desloratadine Administered Concomitantly With Oxybutynin, in Subjects With Seasonal Allergic Rhinitis and Post-Nasal Drip.

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anterior rhinorrhea averaged over Days 1 to 8 [ Time Frame: Days 1 to 8 ] [ Designated as safety issue: No ]

Enrollment: 540
Study Start Date: April 2005
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DL
Desloratadine 2.5 mg BID
Drug: desloratadine
desloratadine 2.5 mg twice daily plus placebo twice daily for 7 days.
Other Names:
  • SCH 34117
  • Clarinex
Active Comparator: OXY
Oxybutynin 5 mg BID
Drug: Oxybutynin
Oxybutynin 5 mg BID plus placebo BID for 7 days
Other Name: Ditropan
Experimental: DL + OXY 2.5
Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID
Drug: desloratadine
desloratadine 2.5 mg twice daily plus placebo twice daily for 7 days.
Other Names:
  • SCH 34117
  • Clarinex
Drug: Oxybutynin
Oxybutynin 2.5 mg BID plus placebo BID for 7 days
Experimental: DL + OXY 5
Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID
Drug: desloratadine
desloratadine 2.5 mg twice daily plus placebo twice daily for 7 days.
Other Names:
  • SCH 34117
  • Clarinex
Drug: Oxybutynin
Oxybutynin 5 mg BID plus placebo BID for 7 days
Other Name: Ditropan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00816972     History of Changes
Other Study ID Numbers: P04258
Study First Received: January 5, 2009
Last Updated: January 5, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Oxybutynin
Desloratadine
Mandelic Acids
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Therapeutic Uses
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on August 27, 2014