Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
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
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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:
|
|
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:
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:
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
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 Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections Oxybutynin Desloratadine Loratadine 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 Anti-Infective Agents, Urinary Anti-Infective Agents Therapeutic Uses Renal Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013