ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00816972
Recruitment Status : Completed
First Posted : January 6, 2009
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post-nasal Drip Seasonal Allergic Rhinitis Rhinorrhea Drug: Desloratadine 2.5 mg Drug: Oxybutynin 2.5 mg Drug: Placebo for Desloratadine 2.5 mg Drug: Placebo for Oxybutynin 2.5 mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2005
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: DL 2.5 mg
Desloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days
Drug: Desloratadine 2.5 mg
Desloratadine 2.5 mg BID
Other Names:
  • SCH 034117
  • Clarinex
Drug: Placebo for Oxybutynin 2.5 mg
Placebo BID
Active Comparator: OXY 5 mg
Placebo for Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days
Drug: Oxybutynin 2.5 mg
Oxybutynin 2.5 mg BID
Other Name: Ditropan
Drug: Placebo for Desloratadine 2.5 mg
Placebo BID
Experimental: DL 2.5 mg + OXY 2.5 mg
Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days
Drug: Desloratadine 2.5 mg
Desloratadine 2.5 mg BID
Other Names:
  • SCH 034117
  • Clarinex
Drug: Oxybutynin 2.5 mg
Oxybutynin 2.5 mg BID
Other Name: Ditropan
Drug: Placebo for Oxybutynin 2.5 mg
Placebo BID
Experimental: DL 2.5 mg + OXY 5 mg
Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days
Drug: Desloratadine 2.5 mg
Desloratadine 2.5 mg BID
Other Names:
  • SCH 034117
  • Clarinex
Drug: Oxybutynin 2.5 mg
Oxybutynin 2.5 mg BID
Other Name: Ditropan
Placebo Comparator: Placebo
Placebo for Desloratadine 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days
Drug: Placebo for Desloratadine 2.5 mg
Placebo BID
Drug: Placebo for Oxybutynin 2.5 mg
Placebo BID



Primary Outcome Measures :
  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 Outcome Measures :
  1. Anterior rhinorrhea averaged over Days 1 to 8 [ Time Frame: Days 1 to 8 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00816972     History of Changes
Other Study ID Numbers: P04258
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015

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