CTRI/2010/091/001300已完成3 期
A Phase III, Multicenter, Single blind, Randomized, Comparative, Prospective study to evaluate the Efficacy and Safety of Montelukast and Fexofenadine fixed dose combination tablet Versus Fexofenadine tablet alone in the patients of Allergic Rhinitis.
upin Limited India0 个研究点目标入组 220 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Males and females patients more than 18 years of age.
- •2.Written informed consent signed by patient and willing to comply with the study procedure.
- •3.Patients with diagnosis of Allergic Rhinitis
- •4.Except Allergic Rhinitis patients must be in general good health based on screening, vital, systemic examination and medical history.
- •5.Patients having mild asthma along with Allergic Rhinitis are also allowed to participate provided they used only inhaled, short acting beta-agonists bronchodilators to treat asthma.
- •6.In case of woman of childbearing potential willing to use effective contraception during the study and willing to undergo pregnancy test.
排除标准
- •1.Males and females patients less than 18 years of age.
- •2.Pregnant and lactating women patients.
- •3.Patients not willing to comply with the study protocol and provide written informed consent to participate.
- •4.Patients with Rhinitis medicamentosa, non-allergic rhinitis or substantial structural nasal obstruction.
- •5.Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 month before the trial.
- •6.Patients with upper respiratory tract infection or acute or chronic pulmonary disorder.
- •7.Patients who had initiation of allergen immunotherapy within previous 6 months.
- •8.Participation in any investigational drug trial within the 90 days preceding the screening visit or planned participation in another investigational drug trial at any time during this trial.
- •9.Patients with known hypersensitivity to Montelukast or Fexofenadine or other piperazine derivatives.
- •10.Patients with known history of rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption will also be excluded from the trial.
- •11.Patients with history of hepatic impairment (alcohol related liver disease or cirrhosis), renal impairment, cardiac impairment and patients who had recently undergone a major surgical procedure or any other condition that in the judgment of the investigator not suitable to be recruited in the study.
- •12.The patients who are currently not on for following medications Intranasal or systemic corticosteroids (1 month), Intranasal cromolyn (2 weeks), Intranasal or systemic decongestants (3 days), Intranasal or systemic antihistamines (3 days).
- •13.Expected use of any other medications for allergic rhinitis or conjunctivitis during the treatment period e.g. antihistamines, corticosteroids (inhaled, oral, parenteral, nasal and ophthalmic), cromolyn sodium, nedocromil and inhaled cholinergics. Oral or long acting beta-agonist, theophylline and leukotriene modifiers are also disallowed. Medications that could affect nasal or ocular symptoms including decongestants and anti-inflammatory drugs are not permitted. No allergic rhinitis rescue medications are permitted during the study.
研究者
相似试验
进行中（未招募）
1 期
Safety and immunogenicity of repeated annual exposure to the aQIV vaccine in children following vaccination in trials V118_05 and V118_05E1Prophylaxis for influenza virusMedDRA version: 18.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestationsEUCTR2015-003008-22-FIovartis Pharma Services AG486
进行中（未招募）
不适用
A Phase III multicenter, single blind, randomized, comparative, add?on clinical trial, in three parallel groups, to evaluate the efficacy and safety of a new therapy with adipose?derived autologous stem cells for the treatment of complex perianal fistulas in patients without inflammatory bowel disease FATT I: Fistula Advanced Therapy Trial (I) - FATT 1Treatment of complex perianal fistulas in patients without inflammatory bowel disease.MedDRA version: 8.1Level: LLTClassification code 10002156Term: Anal fistulaEUCTR2006-003370-95-DECELLERIX, S.L.207
进行中（未招募）
不适用
A Phase III multicenter, single blind, randomized, comparative, add?on clinical trial, in three parallel groups, to evaluate the efficacy and safety of a new therapy with adipose?derived autologous stem cells for the treatment of complex perianal fistulas in patients without inflammatory bowel disease FATT I: Fistula Advanced Therapy Trial (I) - FATT 1Treatment of complex perianal fistulas in patients without inflammatory bowel disease.MedDRA version: 8.1Level: LLTClassification code 10002156Term: Anal fistulaEUCTR2006-003370-95-NLCELLERIX, S.L.207
进行中（未招募）
1 期
A Phase III multicenter, single blind, randomized, comparative, add?on clinical trial, in three parallel groups, to evaluate the efficacy and safety of a new therapy with adipose?derived autologous stem cells for the treatment of complex perianal fistulas in patients without inflammatory bowel disease FATT I: Fistula Advanced Therapy Trial (I)EUCTR2006-003370-95-ESCELLERIX, S.L.207
已完成
3 期
Comparison of Olmesartan +Amlodipine +Hydrochlorothiazide combination with Olmesartan +Hydrochlorothiazide combination in essential hypertension.CTRI/2010/091/006071Aristo Pharmaceuticals Pvt. Ltd. 23-Off veera desai road, Andheri W Mumbai-400053220