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

January 5, 2009
July 21, 2015
April 2005
June 2005   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00816972 on ClinicalTrials.gov Archive Site
Anterior rhinorrhea averaged over Days 1 to 8 [ Time Frame: Days 1 to 8 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)
Pilot Efficacy and Safety Field Trial of Desloratadine Administered Concomitantly With Oxybutynin, in Subjects With Seasonal Allergic Rhinitis and Post-Nasal Drip
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Post-nasal Drip
  • Seasonal Allergic Rhinitis
  • Rhinorrhea
  • 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 Desloratadine 2.5 mg
    Placebo BID
  • Drug: Placebo for Oxybutynin 2.5 mg
    Placebo BID
  • Active Comparator: DL 2.5 mg
    Desloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days
    Interventions:
    • Drug: Desloratadine 2.5 mg
    • Drug: Placebo for Oxybutynin 2.5 mg
  • Active Comparator: OXY 5 mg
    Placebo for Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days
    Interventions:
    • Drug: Oxybutynin 2.5 mg
    • Drug: Placebo for Desloratadine 2.5 mg
  • 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
    Interventions:
    • Drug: Desloratadine 2.5 mg
    • Drug: Oxybutynin 2.5 mg
    • Drug: Placebo for Oxybutynin 2.5 mg
  • Experimental: DL 2.5 mg + OXY 5 mg
    Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days
    Interventions:
    • Drug: Desloratadine 2.5 mg
    • Drug: Oxybutynin 2.5 mg
  • Placebo Comparator: Placebo
    Placebo for Desloratadine 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days
    Interventions:
    • Drug: Placebo for Desloratadine 2.5 mg
    • Drug: Placebo for Oxybutynin 2.5 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
540
June 2005
June 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00816972
P04258
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP