- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00637585
Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine
January 10, 2011 updated by: Sanofi
A Comparison of Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine
To examine the relative potency, onset of action and duration of action of fexofenadine HCl 180 mg (ALLEGRA) and desloratadine 5 mg (CLARINEX) as compared to placebo on skin wheals and flares induced by histamine.
Study Overview
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 55 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female subjects, 12 to 55 years of age, may participate
- Positive histamine skin prick tests (or duplicate histamine skin prick test) with a summation flare (ΣF) greater than or equal to 20 mm larger than diluent control, and summation wheal (ΣW) greater than or equal to 6 mm larger than diluent control at the screening visit 1
- All female subjects must have a negative urine pregnancy test at the screening visit
- Female subjects who are sexually active will be expected to use one of the following birth control methods throughout the study (see Section 4.4)
- Subjects must be within 15% of normal body weight for height or a BMI less than 29.9 (based on NHLBI guidelines)
- Subjects willing and able to adhere to visit schedules and all study requirements
- All female subjects must have a negative urine pregnancy test at each treatment visit (Visit 2, 4, and 6).
- Continues to meet all inclusion and exclusion criteria
Exclusion Criteria:
- Asthma that requires treatment with medication other than an inhaled, short-acting beta agonist
- Signs and symptoms of currently active allergic disease (seasonal allergic rhinitis, perennial allergic rhinitis, episodic allergic rhinitis)
- Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to visit 1
- Subjects who have dermatographism or other skin conditions which might interfere with the interpretation of the skin test results
- Subjects who are receiving immunotherapy
- Any excessive amounts of alcohol (no more than two drinks/day on average)
- Any excessive use of caffeine (more than six cups of coffee per day or equivalent)
- Any use of tobacco/nicotine products within 90 days of visit 1
- Any disease state or surgery known to affect the gastrointestinal absorption of drugs
- Known hypersensitivity to the investigational product or to drugs with similar chemical properties
- Subjects who will be visiting a tanning salon during the study
- Subjects who will need to use artificial tanning products during the study
- Night or variable shift workers during the study
- Pregnancy
- Breast-feeding
- History of hypersensitivity to the study medications or to drugs with similar chemical structures
- Treatment with other H1-receptor antagonists in the last year before study entry
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 6.2)
- Treatment with any investigational product in the last 30 days before study entry
- No person or child of a person directly associated with the administration of the study may participate as a study subject
- Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- Use of any of the following drugs within the time indicated prior to the first dosing visit:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Size of change in summation skin flares from baseline will be measured.
Time Frame: Post-dose (20 min, 40 min, 60 min, and hourly through 12 hours with an additional 2 time points obtained at Hours 23 and 24)
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Post-dose (20 min, 40 min, 60 min, and hourly through 12 hours with an additional 2 time points obtained at Hours 23 and 24)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Size of change in summation skin wheals from baseline will be measured.
Time Frame: Post-dose (20 min, 40 min, 60 min, and hourly through 12 hours with an additional 2 time points obtained at Hours 23 and 24).
|
Post-dose (20 min, 40 min, 60 min, and hourly through 12 hours with an additional 2 time points obtained at Hours 23 and 24).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2002
Study Completion (Actual)
July 1, 2003
Study Registration Dates
First Submitted
March 10, 2008
First Submitted That Met QC Criteria
March 11, 2008
First Posted (Estimate)
March 18, 2008
Study Record Updates
Last Update Posted (Estimate)
January 11, 2011
Last Update Submitted That Met QC Criteria
January 10, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Fexofenadine
Other Study ID Numbers
- M016455A_4145
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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