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

NCT ID: NCT01033396

Last Updated: 2010-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-03654764 + Allegra

Group Type EXPERIMENTAL

PF-03654764

Intervention Type DRUG

PF-03654764 single dose 5 mg

Allegra

Intervention Type DRUG

Fexofenadine single dose 60 mg

PF-03654764

Group Type EXPERIMENTAL

PF-03654764

Intervention Type DRUG

PF-03654764 single dose 5 mg

Allegra-D

Group Type ACTIVE_COMPARATOR

Allegra-D

Intervention Type DRUG

Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo single dose

Interventions

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PF-03654764

PF-03654764 single dose 5 mg

Intervention Type DRUG

Allegra

Fexofenadine single dose 60 mg

Intervention Type DRUG

PF-03654764

PF-03654764 single dose 5 mg

Intervention Type DRUG

Allegra-D

Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose

Intervention Type DRUG

Placebo

Placebo single dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 25024716 (View on PubMed)

Related Links

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Other Identifiers

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B0711005

Identifier Type: -

Identifier Source: org_study_id

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