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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.

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergy

Intervention: Fexofenadine HCI (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Phyllis Diener, Study Director, Affiliation: Sanofi

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.

Clinical Details

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Size of change in skin flares from baseline measured at pre-specified times post-dose.

Secondary outcome: Size and change in skin wheals from baseline measured at pre-specified time points.

Eligibility

Minimum age: 12 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Sanofi-Aventis, Bridgewater, New Jersey 08807, United States
Additional Information

Starting date: November 2002
Last updated: January 10, 2011

Page last updated: August 23, 2015

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