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

Verified by: Pfizer, August 2010
First Received: December 14, 2009 | Last Updated: August 16, 2010 | Phase: Phase 2 | Start Date: January 2010
Overall Status: Completed | Estimated Enrollment: 64
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PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed...

Brief Summary

Official Title: “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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: May 2010

Intervention(s) in this Clinical Trial

  • Drug: PF-03654764
    • PF-03654764 single dose 5 mg
  • Drug: Allegra
    • Fexofenadine single dose 60 mg
  • Drug: PF-03654764
    • PF-03654764 single dose 5 mg
  • Drug: Allegra-D
    • Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose
  • Drug: Placebo
    • Placebo single dose

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: PF-03654764 + Allegra
  • Experimental: PF-03654764
  • Active Comparator: Allegra-D
  • Placebo Comparator: Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Congestion scores
    • Time Frame: 6 hours
      Safety Issue?: No
  • Other allergic rhinitis symptoms
    • Time Frame: 6 hours
      Safety Issue?: No

Secondary Measures

  • Pharmacokinetics
    • Time Frame: 6 hours
      Safety Issue?: No
  • Blood pressure/pulse rate
    • Time Frame: 6 hours
      Safety Issue?: Yes
  • Adverse event reporting
    • Time Frame: 2 months
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01033396

Study ID Number: B0711005

ClinicalTrials.gov Identifier: NCT01033396

Health Authority: Canada: Health Authority

To obtain contact information for a study center near you, click here.

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01033396