Expired Study
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Bridgewater, New Jersey 08807


Purpose:

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.


Criteria:

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:


NCT ID:

NCT00637585


Primary Contact:

Study Director
Phyllis Diener
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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