CTRI/2010/091/000517未知3 期
An Open-label, Assessor-blind, Randomized, Active-controlled Clinical Trial to Evaluate Safety, Tolerability and Efficacy of Oral Tablets of Fixed-dose Combination of Montelukast Sodium equivalent to Montelukast 10 mg and Fexofenadine Hydrochloride 120 mg manufactured by Theon Pharmaceuticals Ltd with Oral Tablets of Fexofenadine Hydrochloride 120 mg alone manufactured by Sanofi Aventis Pharmaceuticals Inc. in the treatment of persistent allergic rhinitis
M/S. Theon Pharmaceuticals Ltd.4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 待定
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- The primary objective of this trial is to evaluate any difference between oral tablets of the fixed-dose combination of montelukast 10 mg and fexofenadine 120 mg with Allegra oral tablets, which is Fexofenadine hydrochloride 120 mg alone in treatment of persistent allergic rhinitis in terms of efficacy by virtue of symptomatic improvement during the ten-day study duration.
研究概览
简要总结
This study is a randomized, open label, parallel group, multi centre trial comparing the safety efficacy of Fexofenadine 120mg and Montelukast 10 mg daily for 2 months in 200 patients with allergic rhinitis that will be conducted in four centres in India
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •Subjects in the age group of 18-75 years (age of assent)Written and/or witnessed informed consent to participate in the trial was taken prior to initiating the study from the parent and/ or the legally accepted representative.Patients who had at least 6 months previous history of confirmed diagnosis of allergic rhinitisA positive skin-prick test response to at least 1 of 8 allergens [house dust, grass pollens, tree pollens, ragweeds, seasonal allergens, cat fur, cockroach and strong odors]Clinically symptomatic at Screening and at the Baseline VisitsPatients with nasal congestion score of at least 2 using a 4-point scale (0 = none, 3 = severe)Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluationsPatients who did not receive either of the study medication Women with negative pregnancy test on the randomization dayWomen in childbearing age group agreed to use appropriate contraception during the trial.
排除标准
- •Patients known, or thought to be hypersensitivity to study drugsPatients having had upper respiratory tract infection during the 6-week period preceding the study Patients with septal deviation, nasal polyps, acute or chronic rhinosinusitisPatients with any other condition that might affect nasal breathing or nocturnal sleep patternHistory of nasal reconstructive surgery Patients with abnormal liver and kidney function History of asthma or asthmatic bronchitisElectrocardiographic abnormalities including conduction delay and an abnormal QTc intervalHistory of auto-immune disease History of chronic lung disease Excluded medications were astemizole within 3 months; oral or parenteral corticosteroids within 1 month; cromolyn, nedocromil, or nasal or ophthalmic corticosteroids within 2 weeks; cetirizine, zilenton, zafirlukast, oral or long-acting inhaled 13-adrenergic agonists or inhaled anticholinergic agents within 1 week; terfenadine, loratadine, or fexofenadine within 72 hours; and short-acting antihistamines and decongestants within 24 hours before visitConcurrent use of antibiotics, antivirals, nasal steroids, decongestants or antihistamines Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion Participation in other clinical trials the last three months and during study participation.
结局指标
主要结局
The primary objective of this trial is to evaluate any difference between oral tablets of the fixed-dose combination of montelukast 10 mg and fexofenadine 120 mg with Allegra oral tablets, which is Fexofenadine hydrochloride 120 mg alone in treatment of persistent allergic rhinitis in terms of efficacy by virtue of symptomatic improvement during the ten-day study duration.
时间窗: 10 days
次要结局
- The secondary objective of this trial is to evaluate any difference between oral tablets of the fixed-dose combination of montelukast 10 mg and fexofenadine 120 mg with Allegra oral tablets, which is Fexofenadine hydrochloride 120 mg alone in treatment of persistent allergic rhinitis in terms of safety by virtue of comparing adverse events in each arm throughout the trial duration and clinical chemistry profiles at the baseline and end-of-study.(end of study)
研究者
研究点 (4)
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