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Bridgewater, New Jersey 08807


Compare the effect of a single dose of fexofenadine HCl 180 mg plus orange juice versus placebo plus orange juice on the change from baseline (pre-dose) in histamine skin flares.


Inclusion Criteria: - Healthy male or non-pregnant, non-lactating female subjects; 12-55 years of age; within 15% of normal body weight for their height or had a body mass index (BMI) less than 29.9 kg/m2; positive histamine skin prick tests (or a duplicate histamine skin prick test) of summation flare > 20 mm larger than diluent control, and summation wheal > 6 mm larger than diluent control at the screening Visit 1. Exclusion Criteria: - Asthma that required treatment with medication other than an inhaled, short-acting beta agonist - Signs and symptoms of currently active allergic disease (SAR, perennial allergic rhinitis, episodic allergic rhinitis) - Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to Visit 1 - Dermatographism or other skin conditions that might interfere with the interpretation of the skin test results - Treatment with escalating doses of immunotherapy, oral immunotherapy, or short course (rush) 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 history of chronic alcohol or mood-altering drug abuse - 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 - Treatment with an H1-receptor antagonist regularly within the past year before study entry - Known hypersensitivity to the investigational product or to drugs with similar chemical properties, or to orange juice - Need to visit a tanning salon during the study - Need to use artificial tanning products during the study - Pregnancy - Breast-feeding - 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 - 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 - Unlikelihood of complying 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 (Time prior to Visit 2): - Systemic or injected corticosteroids (including oral, parenteral, intravenous, rectal)(30 days). - Nasal or inhaled or ocular corticosteroids (30 days). - Nasal or inhaled ipratropium bromide (or atropine), inhaled nedocromil, or nasal, inhaled, or ophthalmic sodium cromolyn (14 days) - Agents with antihistaminic/anticholinergic activity (e.g.antidepressants, antipsychotics)(14 days). - Leukotriene pathway modifiers (Accolate®, Singulair®, Zyflo®) 10 days Ocular anti-allergy medications including lodoxamide (Alomide®), olopatadine (Patanol®), emedastine difumarate (Emadine®), levocabastine (Livostin®) (10 days). - Non-steroidal anti-inflammatory ophthalmics including ketorolac (Acular®), flurbiprofen (Ocufen®), suprofen (Profenal®), diclofenac (Voltaren®) (10 days). - Antihistamines including desloratadine (Clarinex®), loratadine (Claritin®)(10 days). - Fexofenadine HCl (Allegra®), cetirizine (Zyrtec®), hydroxyzine, azelastine nasal spray (Astelin®), clemastine (7 days) - Other short-acting antihistamines such as chlorpheniramine or drugs with antihistaminic activity (3 days). - OTC oral antihistamines, decongestants (includes pseudoephedrine and other decongestants), or antihistamines/decongestant combinations including all cold, cough, and sleep aids (3 days). - OTC ophthalmic decongestant, antihistamine, or decongestant/ antihistamine combinations (3 days). - Other anticholinergic agents (3 days). - Immunotherapy injection (1 day). - Other drugs were to be permitted if they were not expected to interfere with the ability of the subject to participate in the study. - Non-steroidal anti-inflammatory agents were not allowed for 2 days prior to each treatment visit day through 24 hours post-dose. - Medications or agents not specified above that might confound the interpretation of the results were prohibited as follows: - Caffeine within 6 hours prior to each visit (coffee, tea, cola, including Mountain Dew and Surge). - Decaffeinated coffee, tea and colas within 6 hours of each visit - Alcohol within 24 hours prior to each study visit. - Chocolate within 6 hours prior to each visit. - Antacids within + 2 hours of investigational product dosing. - Any waiver of these inclusion and exclusion criteria required approval by the investigator and the sponsor on a case-by-case basis prior to enrolling the subject. Approval had to be documented by both the sponsor and the investigator. - No subject was to be allowed to enroll in this study more than once.



Primary Contact:

Study Director
Phyllis Diener

Backup Contact:


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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