A Prospective, Randomized Double Blind, Active Controlled, parallel Comparative Clinical Study to Evaluate the Efficacy and Safety of DEXAMETHASONE-AGIO (Dexamethasone sodium phosphate 4mg/ml) Injection of Agio Pharmaceuticals Ltd. Mumbai, India with DEXAMETHASONE (Dexamethasone sodium phosphate 4mg/ml) Injection of the company KRKA Slovenia in the treatment of severe or incapacitating allergic conditions of skin and respiratory tract

Agio Pharmaceuticals Ltd1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2017年10月25日最近更新: 2021年2月18日

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 60
试验地点: 1
主要终点: Patients with skin allergies

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A prospective randomised Double blind active controlled parallel comparative clinical study to Evaluate the efficacy and safety of Dexamethasone Agio injection of AGIO Pharmaceuticals Ltd. Mumbai with Dexamethason Injection of KRKA Slovenia in the treatment of severe or incapcitating allergic conditions of skin and respiratory tract Duration Of the study for 17 days Total Number of Subjects 60

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.
•Patients with severe or incapacitating allergic conditions: Bronchial asthma Acute allergic bronchitis Contact dermatitis Atopic dermatitis Seasonal or perennial allergic rhinitis Drug hypersensitivity reactions Urticarial transfusion reactions Acute noninfectious laryngeal edema.

排除标准

•Patients who are not willing to give written informed consent
•A medical history of significant hypersensitivity or allergic reaction to dexamethasone or any corticosteroids.
•Current chronic use of steroids
•patients with smoking habit
•Patients being treated with antibiotics
•Participation in any clinical trials prior to 12 months
•Current treatment with immune-suppressants (eg, cyclosporine or methotrexate)
•Current treatment with phototherapy (UVA, UVB, PUVA and lasers)
•Use of systemic corticosteroids in the visit to include Topical treatments at the site of lesions in the 15 days preceding the survey
•Presence of secondary infections at the site of treatment, diagnosed clinically; 11.Presence of other eczematous diseases, such as nummular eczema, neurodermatitis, seborrheic dermatitis, psoriasis, scabies, and Buckleys syndrome
•Pregnant or lactating women
•Chronic alcoholism
•Any finding of clinical observation (clinical history or physical examination) that is interpreted by the physician investigator as a risk to the patients participation in the study.
•History of diabetic mellitus, thyroid dysfunction
•Current or suspected diagnosis of viral, fungal, non infectious causes of pulmonary infiltrates, lung cancer, cystic fibrosis, tuberculosis,
•History of muscle weakness
•Severely immunocompromised patients
•Bacteremia and systemic fungal infections, glaucoma, hypersensitivity to any of the products components, Cushingâ€™s syndrome, gastric and duodenal ulcers, certain viral infections, i.e. varicella, herpes genita previous or current exposure to chicken pox, varicella virus and measles or have taken vaccination for the same.
•Patients with positive serology laboratory values.
•History of intubations for asthma or co morbidities (Chronic Lung Disease (CLD), Congenital Heart Defects (CHD), or neurologic disorders).