Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-02-20 @ 4:47 PM
Study NCT ID:
NCT00547768
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2007-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2002-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-10', 'studyFirstSubmitDate': '2007-10-22', 'studyFirstSubmitQcDate': '2007-10-22', 'lastUpdatePostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Size of change in skin flares from baseline measured at pre-specified times post-dose.', 'timeFrame': '20 min, 40 min, 60 min, and hourly through 12 hours, with an additional 2 time points obtained at Hours 23 and 24.'}], 'secondaryOutcomes': [{'measure': 'Size and change in skin wheals from baseline measured at pre-specified time points.', 'timeFrame': '20 min, 40 min, 60 min, and hourly through 12 hours, with an additional 2 time points.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Asthma that required treatment with medication other than an inhaled, short-acting beta agonist\n* Signs and symptoms of currently active allergic disease (SAR, perennial allergic rhinitis, episodic allergic rhinitis)\n* Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to Visit 1\n* Dermatographism or other skin conditions that might interfere with the interpretation of the skin test results\n* Treatment with escalating doses of immunotherapy, oral immunotherapy, or short course (rush) immunotherapy\n* Any excessive amounts of alcohol (no more than two drinks/day on average)\n* Any excessive use of caffeine (more than six cups of coffee per day or equivalent)\n* Any history of chronic alcohol or mood-altering drug abuse\n* Any use of tobacco/nicotine products within 90 days of visit 1\n* Any disease state or surgery known to affect the gastrointestinal absorption of drugs\n* Treatment with an H1-receptor antagonist regularly within the past year before study entry\n* Known hypersensitivity to the investigational product or to drugs with similar chemical properties, or to orange juice\n* Need to visit a tanning salon during the study\n* Need to use artificial tanning products during the study\n* Pregnancy\n* Breast-feeding\n* Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 6.2)\n* Treatment with any investigational product in the last 30 days before study entry\n* Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult\n* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study\n* Unlikelihood of complying with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.\n* Use of any of the following drugs within the time indicated prior to the first dosing visit (Time prior to Visit 2):\n* Systemic or injected corticosteroids (including oral, parenteral, intravenous, rectal)(30 days).\n* Nasal or inhaled or ocular corticosteroids (30 days).\n* Nasal or inhaled ipratropium bromide (or atropine), inhaled nedocromil, or nasal, inhaled, or ophthalmic sodium cromolyn (14 days)\n* Agents with antihistaminic/anticholinergic activity (e.g.antidepressants, antipsychotics)(14 days).\n* Leukotriene pathway modifiers (Accolate®, Singulair®, Zyflo®) 10 days Ocular anti-allergy medications including lodoxamide (Alomide®), olopatadine (Patanol®), emedastine difumarate (Emadine®), levocabastine (Livostin®) (10 days).\n* Non-steroidal anti-inflammatory ophthalmics including ketorolac (Acular®), flurbiprofen (Ocufen®), suprofen (Profenal®), diclofenac (Voltaren®) (10 days).\n* Antihistamines including desloratadine (Clarinex®), loratadine (Claritin®)(10 days).\n* Fexofenadine HCl (Allegra®), cetirizine (Zyrtec®), hydroxyzine, azelastine nasal spray (Astelin®), clemastine (7 days)\n* Other short-acting antihistamines such as chlorpheniramine or drugs with antihistaminic activity (3 days).\n* OTC oral antihistamines, decongestants (includes pseudoephedrine and other decongestants), or antihistamines/decongestant combinations including all cold, cough, and sleep aids (3 days).\n* OTC ophthalmic decongestant, antihistamine, or decongestant/ antihistamine combinations (3 days).\n* Other anticholinergic agents (3 days).\n* Immunotherapy injection (1 day).\n* Other drugs were to be permitted if they were not expected to interfere with the ability of the subject to participate in the study.\n* Non-steroidal anti-inflammatory agents were not allowed for 2 days prior to each treatment visit day through 24 hours post-dose.\n* Medications or agents not specified above that might confound the interpretation of the results were prohibited as follows:\n* Caffeine within 6 hours prior to each visit (coffee, tea, cola, including Mountain Dew and Surge).\n* Decaffeinated coffee, tea and colas within 6 hours of each visit\n* Alcohol within 24 hours prior to each study visit.\n* Chocolate within 6 hours prior to each visit.\n* Antacids within + 2 hours of investigational product dosing.\n* 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.\n* No subject was to be allowed to enroll in this study more than once.'}, 'identificationModule': {'nctId': 'NCT00547768', 'briefTitle': '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.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'orgStudyIdInfo': {'id': 'M016455A_4144'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fexofenadine HCI', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}], 'overallOfficials': [{'name': 'Phyllis Diener', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}