Multicenter Pilot Study to Assess the Feasibility of Conducting Phase III Trial Comparing IV Cetirizine Injection, 10 mg, to IV Diphenhydramine, 50 mg, for The Treatment of Acute Urticaria
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Extent of Urticaria/Erythema Score (Physician Assessment)
研究概览
简要总结
This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 36 patients with acute urticaria requiring treatment in Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics.
详细描述
Multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 36 patients with acute urticaria requiring treatment in Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics. This study will be conducted in 33 patient who either present themselves to the hospital emergency department, allergy clinic or urgent care centers with acute urticaria or developed acute urticaria following a allergen challenge at an allergy clinic.
Following informed consent, eligibility will be established, capturing baseline data including vitals, age, medical history, and medications taken prior to coming to the clinical study site. Following data collection, study subjects will be randomized in a 1:1 ratio to receive study drug of either cetirizine 10 mg IV or diphenhydramine, 50 mg IV. Baseline data including vital signs, the extent of urticaria and erythema, the severity of pruritus, and the level of sedation will be recorded prior to and at 1 hour and 2 hours post study drug administration, and at the time of "Readiness for Discharge". The actual time at which the investigator determines that the subject is ready for discharge (physically and mentally fit) from the study site will also be recorded. At these same time intervals, subjects will be asked to self-rate (recorded by study staff) severity of their pruritus and level of sedation (recorded by study staff).
Twenty-four hours following discharge from the study site, study staff will call the subject to ask them a few short questions to follow-up on the treatment of their acute urticaria. All adverse and serious adverse events experienced by the subjects following informed consent, and all data captured will be recorded in the source documents and/or case report forms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with a diagnosis of acute urticaria associated with an acute allergic reaction to a known (e.g. food, medication, insect bites) or unknown allergen who need treatment with an injectable antihistamine to alleviate their symptoms;
- •18 years of age or older;
- •Be willing and able to give informed consent;
- •Patients with a Physician Pruritus Severity Score ≥ 1 (determined by the investigator);
- •Patients with an Extent of Urticaria/Erythema Score ≥ 1 (determined by the investigator).
排除标准
- •Receipt of an investigational drug or device, within the past 30 days;
- •Patients in whom an antihistamine may be contraindicated (e.g. narrow angle glaucoma, symptomatic prostatic hypertrophy);
- •Patients who, in the opinion of the investigator, may not tolerate an IV injection of diphenhydramine 50 mg, or cetirizine 10 mg;
- •Receipt of any antihistamine (H1 antagonist) within the past 4 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine;
- •Receipt of an H2 antagonist within the past 12 hours;
- •Receipt of doxepin within the past 48 hours; doxepin is an antidepressant, but it also has antihistamine properties;
- •Receipt of steroids by the oral, IV, IM, or inhalational routes route within the past 48 hours to manage an acute allergic reaction;
- •Receipt of epinephrine (EpiPen or any other brand) within the past 1 hour;
- •Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine;
- •Pregnancy or breastfeeding;
- •Patients who require epinephrine immediately to manage their acute allergic symptoms;
- •Patients who have an acute reaction to medication they are taking (e.g. antibiotics, ACE inhibitors, NSAIDs) and who cannot stop the medication;
- •Patients who, based on their medical history or in the opinion of the investigator, have chronic idiopathic urticaria, hereditary angioedema, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response;
- •Urticaria not associated with an acute allergic reaction;
- •Any condition that in the view of the investigator makes the subject unsuitable for enrollment in this study;
- •History of HIV or other known immunodeficiency;
- •Major medical or psychiatric illness, other than acute urticaria, at the time of presentation;
- •Inability to provide informed consent.
研究组 & 干预措施
Test Drug
JDP-205 Injection, 10 mg/mL, 1 mL
干预措施: JDP-205 Injection (Drug)
Control
Diphenhydramine Injection, 50 mg/mL, 1 mL
干预措施: Diphenhydramine (Drug)
结局指标
主要结局
Extent of Urticaria/Erythema Score (Physician Assessment)
时间窗: Baseline, 1 hour, 2 hour, Discharge (up to 4 hours)
Extent of Urticaria/Erythema Score (Physician Assessment), capturing extent of urticaria/erythema, using the Body Chart (adopted from Burn Chart). Extent of Urticaria/Erythema Score is the average of the 2 scores: 1. Percentage of body area using the body chart (adopted from burn Chart) 0 = none, 1= mild (,25% body coverage), 2 = moderate (25-50% body coverage, 3 = Severe/intense .50% body coverage 2. Intensity of redness (adopted from PASI) 0 = none, 1 = mile (light pink) 2= moderate (pink), 3 =severe/intense (red)
Composite Acute Urticaria Score Change From Baseline
时间窗: Baseline, 1 hour, 2 hour, Discharge (an average of 1 day)
A composite acute urticaria score, the sum of Extent of urticaria/erythema score (Physician), Physician pruritis score and Patient pruritis severity score. A composite acute urticaria score which the sum of the above three parameters (i.e. 0-9) was calculated post hoc for each patient at each time point and then their score change from the baseline were compared between the two treatment groups. Higher values indicate a worse outcome.
Physician Pruritus Severity Score
时间窗: Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first
Physician Pruritus Severity Score based on patient expression of severity of itchiness. 0= none 1 = Mild (patient expresses itchiness but tolerable, and does not scratch 2= moderate definite awareness, bothersome, intermittently scratch affected area 3= severe difficult to tolerate scratch vigorously
Patient Pruritis Severity Score
时间窗: Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first
Patient Pruritis Severity Score based on severity of itching at time of assessment. How severly are your hives itching at the moment? 0 = none 1= mild minimal awareness easily tolerated 2 = moderate definite awareness quite bothersome 3= severe difficult to tolerate
次要结局
- Sedation Scores and Time to Readiness for Discharge(Assessed at discharge or up to 4 hours post intervention, whichever came first data at discharge reported.)
- Percentage of Patients Requiring Additional Medication(Baseline, 1 hour, 2 hour, Discharge (an average of 1 day))
- Sedation Scores and Time to Readiness for Discharge HH:MM(Assessed at discharge or up to 4 hours post intervention, whichever came first data at discharge reported.)