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

Tracking Information
First Received Date ^ICMJE	January 5, 2009
Last Updated Date	January 5, 2009
Start Date ^ICMJE	April 2005
Primary Completion Date	June 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 5, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: January 5, 2009)	Anterior rhinorrhea averaged over Days 1 to 8 [ Time Frame: Days 1 to 8 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)
Official Title ^ICMJE	Pilot Efficacy and Safety Field Trial of Desloratadine Administered Concomitantly With Oxybutynin, in Subjects With Seasonal Allergic Rhinitis and Post-Nasal Drip.
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Post-Nasal Drip Seasonal Allergic Rhinitis Rhinorrhea
Intervention ^ICMJE	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 Drug: Oxybutynin Oxybutynin 2.5 mg BID plus placebo BID for 7 days
Study Arm (s)	Active Comparator: DL Desloratadine 2.5 mg BID Intervention: Drug: desloratadine Active Comparator: OXY Oxybutynin 5 mg BID Intervention: Drug: Oxybutynin Experimental: DL + OXY 2.5 Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID Interventions: Drug: desloratadine Drug: Oxybutynin Experimental: DL + OXY 5 Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID Interventions: Drug: desloratadine Drug: Oxybutynin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	540
Completion Date	June 2005
Primary Completion Date	June 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00816972
Other Study ID Numbers ^ICMJE	P04258
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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