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The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01033396
First received: December 14, 2009
Last updated: August 16, 2010
Last verified: August 2010
History of Changes

December 14, 2009
August 16, 2010
January 2010
May 2010   (final data collection date for primary outcome measure)
  • Congestion scores [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Other allergic rhinitis symptoms [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01033396 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Blood pressure/pulse rate [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
  • Adverse event reporting [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis
A Randomized, Double Blind, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of PF-03654764 +/- Allegra (Fexofenadine) On Symptoms Of Allergic Rhinitis In Subjects Exposed To Ragweed Pollen In An Environmental Exposure Unit.

PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Allergic Rhinitis
  • Drug: PF-03654764
    PF-03654764 single dose 5 mg
  • Drug: Allegra
    Fexofenadine single dose 60 mg
  • Drug: Allegra-D
    Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose
  • Drug: Placebo
    Placebo single dose
  • Experimental: PF-03654764 + Allegra
    Interventions:
    • Drug: PF-03654764
    • Drug: Allegra
  • Experimental: PF-03654764
    Intervention: Drug: PF-03654764
  • Active Comparator: Allegra-D
    Intervention: Drug: Allegra-D
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects 18-60 years allergic to ragweed pollen.
  • Subjects with appropriate symptom scores following exposure to ragweed in the environmental exposure unit.

Exclusion Criteria:

  • Subjects with significant diseases other than allergic rhinitis that may interfere with the safety or efficacy of PF-03654764.
  • Subjects with significant symptoms of allergic rhinitis within the 2 weeks prior to screening.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01033396
B0711005
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2010

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