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

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NCT01033396

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Kingston, Ontario, K7L 2V7 Canada
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Allergic Rhinitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01033396
Pfizer
Completed
The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis

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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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
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.
 
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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01033396
B0711005
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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