Working… Menu

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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00547768
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : January 11, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Allergy Drug: Fexofenadine HCI Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : November 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. 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. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   12 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00547768

Layout table for location information
United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Layout table for investigator information
Study Director: Phyllis Diener Sanofi
Layout table for additonal information Identifier: NCT00547768    
Other Study ID Numbers: M016455A_4144
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs