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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

Brief Summary:
PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: PF-03654764 Drug: Allegra Drug: Allegra-D Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : January 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PF-03654764 + Allegra Drug: PF-03654764
PF-03654764 single dose 5 mg
Drug: Allegra
Fexofenadine single dose 60 mg
Experimental: PF-03654764 Drug: PF-03654764
PF-03654764 single dose 5 mg
Active Comparator: Allegra-D Drug: Allegra-D
Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose
Placebo Comparator: Placebo Drug: Placebo
Placebo single dose



Primary Outcome Measures :
  1. Congestion scores [ Time Frame: 6 hours ]
  2. Other allergic rhinitis symptoms [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 6 hours ]
  2. Blood pressure/pulse rate [ Time Frame: 6 hours ]
  3. Adverse event reporting [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033396


Locations
Canada, Ontario
Pfizer Investigational Site
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01033396     History of Changes
Other Study ID Numbers: B0711005
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: August 17, 2010
Last Verified: August 2010

Keywords provided by Pfizer:
Allergic rhinitis Environmental exposure unit

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fexofenadine
Terfenadine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs