The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis
NCT01033396
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- 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.
- 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.
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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |