NCT00547768已完成4 期
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.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Size of change in skin flares from baseline measured at pre-specified times post-dose.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 12 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Size of change in skin flares from baseline measured at pre-specified times post-dose.
时间窗: 20 min, 40 min, 60 min, and hourly through 12 hours, with an additional 2 time points obtained at Hours 23 and 24.
次要结局
- Size and change in skin wheals from baseline measured at pre-specified time points.(20 min, 40 min, 60 min, and hourly through 12 hours, with an additional 2 time points.)
研究者
研究点 (1)
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