The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01033396
First received: December 14, 2009
Last updated: August 16, 2010
Last verified: August 2010
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Purpose
PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinitis |
Drug: PF-03654764 Drug: Allegra Drug: Allegra-D Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Congestion scores [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Other allergic rhinitis symptoms [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetics [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Blood pressure/pulse rate [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
- Adverse event reporting [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 64 |
| Study Start Date: | January 2010 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01033396 History of Changes |
| Other Study ID Numbers: | B0711005 |
| Study First Received: | December 14, 2009 |
| Last Updated: | August 16, 2010 |
| Health Authority: | Canada: Health Authority |
Keywords provided by Pfizer:
|
Allergic rhinitis Environmental exposure unit |
Additional relevant MeSH terms:
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Fexofenadine Anti-Allergic Agents Therapeutic Uses |
Pharmacologic Actions Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013