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

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00816972

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Hay Fever

Drug Information available for: Descarboethoxyloratadine Oxybutynin chloride Oxybutynin

U.S. FDA Resources

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
DL: Active Comparator Desloratadine 2.5 mg BID	Drug: desloratadine desloratadine 2.5 mg twice daily plus placebo twice daily for 7 days.
OXY: Active Comparator Oxybutynin 5 mg BID	Drug: Oxybutynin Oxybutynin 5 mg BID plus placebo BID for 7 days
DL + OXY 2.5: Experimental 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. Drug: Oxybutynin Oxybutynin 2.5 mg BID plus placebo BID for 7 days
DL + OXY 5: Experimental Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID	Drug: desloratadine desloratadine 2.5 mg twice daily plus placebo twice daily for 7 days. Drug: Oxybutynin Oxybutynin 5 mg BID plus placebo BID for 7 days

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

No Contacts or Locations Provided

More Information

No publications provided

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

Study placed in the following topic categories:

Oxybutynin
Neurotransmitter Agents
Otorhinolaryngologic Diseases
Cholinergic Antagonists
Rhinitis
Anti-Allergic Agents
Cholinergic Agents
Desloratadine
Histamine
Muscarinic Antagonists
Hypersensitivity

Histamine Antagonists
Respiratory Tract Diseases
Respiratory Tract Infections
Loratadine
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Antipruritics
Histamine phosphate
Histamine H1 Antagonists
Peripheral Nervous System Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Rhinitis
Cholinergic Agents
Hypersensitivity
Loratadine
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Antipruritics
Dermatologic Agents
Oxybutynin

Otorhinolaryngologic Diseases
Immune System Diseases
Histamine Agents
Anti-Allergic Agents
Desloratadine
Nose Diseases
Pharmacologic Actions
Muscarinic Antagonists
Histamine Antagonists
Autonomic Agents
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine H1 Antagonists
Peripheral Nervous System Agents
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on September 02, 2009