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.

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: October 22, 2007
Last updated: January 10, 2011
Last verified: January 2011

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.

Condition Intervention Phase
Drug: Fexofenadine HCI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Size of change in skin flares from baseline measured at pre-specified times post-dose. [ Time Frame: 20 min, 40 min, 60 min, and hourly through 12 hours, with an additional 2 time points obtained at Hours 23 and 24. ]

Secondary Outcome Measures:
  • Size and change in skin wheals from baseline measured at pre-specified time points. [ Time Frame: 20 min, 40 min, 60 min, and hourly through 12 hours, with an additional 2 time points. ]

Enrollment: 36
Study Start Date: November 2002
Study Completion Date: December 2002

Ages Eligible for Study:   12 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00547768

United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Study Director: Phyllis Diener Sanofi
  More Information

No publications provided Identifier: NCT00547768     History of Changes
Other Study ID Numbers: M016455A_4144
Study First Received: October 22, 2007
Last Updated: January 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
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 processed this record on April 16, 2014