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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00816972
First received: January 5, 2009
Last updated: July 21, 2015
Last verified: July 2015
  Purpose

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 Intervention 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
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 Merck Sharp & Dohme Corp.:

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 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

  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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00816972     History of Changes
Other Study ID Numbers: P04258
Study First Received: January 5, 2009
Last Updated: July 21, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 30, 2015