Comparative Study Evaluating the Effects of Fexofenadine HCI 180 mg With Orange Juice Versus Placebo With Orange Juice in a Skin Wheal and Flare Challenge Model.

Completed · Phase 4

Conditions studied: Allergy

In brief

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.

Key facts

Study ID

NCT00547768

Run by

Sanofi

People needed

36

Starts

2002-11-01

Expected to finish

2002-12-01

Last updated by the study team

2011-01-11

Who can join

Age: 12 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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