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Trial record 1 of 1 for:    NCT01033396
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The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT01033396
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : August 17, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE December 14, 2009
First Posted Date  ICMJE December 16, 2009
Last Update Posted Date August 17, 2010
Study Start Date  ICMJE January 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2009)
  • Congestion scores [ Time Frame: 6 hours ]
  • Other allergic rhinitis symptoms [ Time Frame: 6 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01033396 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2009)
  • Pharmacokinetics [ Time Frame: 6 hours ]
  • Blood pressure/pulse rate [ Time Frame: 6 hours ]
  • Adverse event reporting [ Time Frame: 2 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis
Official Title  ICMJE 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.
Brief Summary PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Allergic Rhinitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * North ML, Walker TJ, Steacy LM, Hobsbawn BG, Allan RJ, Hackman F, Sun X, Day AG, Ellis AK. Add-on histamine receptor-3 antagonist for allergic rhinitis: a double blind randomized crossover trial using the environmental exposure unit. Allergy Asthma Clin Immunol. 2014 Jul 3;10(1):33. doi: 10.1186/1710-1492-10-33. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2009)
64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01033396
Other Study ID Numbers  ICMJE B0711005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2010

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