CTRI/2023/09/057263已完成3 期
Multi-center, randomized, parallel group, active-controlled, open label clinical trial to evaluate efficacy and safety of fixed dose combination syrup of Bilastine 3.3 mg, Dextromethorphan 10 mg and Phenylephrine 5 mg per 5 mL, in patients with cough associated with common cold or allergy
Glenmark Pharmaceuticals Ltd10 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2023年9月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 10
- 主要终点
- Change from baseline to Day 4 in cough severity on a 100 mm Visual Analogue Scale (VAS)
研究概览
简要总结
Thisis a Multi-center, randomized, parallel group, active-controlled, open labelclinical trial to evaluate efficacy and safety of fixed dose combination syrupof Bilastine 3.3 mg, Dextromethorphan 10 mg and Phenylephrine 5 mg per 5 mL, inpatients with cough associated with common cold or allergy
Themaximum total duration of study is of 8 days which consisted of 7 treatmentdays.
The primary outcomemeasures consist of change from baseline in cough severity on 100mm VAS atDay 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age at least 12 years (completed) and less than 65 years (subjects who completed 65th birthday will be excluded) at the time of signing consent/assent.
- •2.Provided written informed consent (pediatric assent and parental consent in case of children < 18 years of age).
- •3.Male or female subjects with acute cough of less than 7 days duration at the time of consent, associated with common cold or allergy.
- •4.Cough severity at least 60 mm on visual analogue scale (VAS) at screening.
- •5.Willing and able to comply with all aspects of the protocol.
- •6.For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pre-treatment urine pregnancy test 7.Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment.
排除标准
- •1.A productive cough with excessive secretions, regardless of colour.
- •2.Subjects with chronic cough (i.e. history of chronic bronchitis in smokers, gastroâ€esophageal reflux, asthma, hyperâ€responsive airways after resolution of respiratory tract infection, COPD, pertussis, aspiration, tumor, tuberculosis or fungal infections).
- •3.Subjects receiving oral or intranasal anti-histamine or cough suppressant or decongestant within 7 days prior to screening.
- •4.Subjects taking angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) within 14 days of consent 5.Pregnant or breastfeeding.
- •6.Positive urine pregnancy test at screening.
- •7.Known hypersensitivity to the study drugs (investigational product or comparator) or any of the excipients.
- •8.Subjects with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the subject’s participation in the study.
- •9.Previous participation in another interventional clinical study within 30 days of first dose in this study.
- •10.Concurrent enrolment in another interventional clinical study.
- •11.Employee of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
- •12.Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- •13.Subjects with history of significant cardiovascular disease, uncontrolled hypertension, uncontrolled diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement or phaeochromocytoma at screening.
- •Subjects receiving monoamine oxidase inhibitor, a selective serotonin reuptake inhibitor, or other medications for depression, psychiatric, or emotional conditions, or Parkinson s disease with within 14 days prior to consent.
结局指标
主要结局
Change from baseline to Day 4 in cough severity on a 100 mm Visual Analogue Scale (VAS)
时间窗: From baseline to Day 4
次要结局
- Drowsiness score on Profile of Mood State (POMS) questionnaire(From Baseline to end of study)
- Change from baseline to Day 8 in cough severity on a 100 mm VAS(From baseline to Day 8)
- Proportion of subjects with resolution of cough symptoms on Day 4 and 8(On Day 4 and Day 8)
- Proportion of subjects with complete clinical cure on Day 4 and 8(On Day 4 and Day 8)
- Patient Global Impression of Change (PGIC) on Day 4 and 8(On Day 4 and Day 8)
- Investigator Global Impression of Change (IGIC) on Day 4 and 8(On Day 4 and Day 8)
- Change from baseline to Day 4 and 8 in cough frequency on a 100 mm VAS(From Baseline to Day 4 and Day 8)
- Change from baseline to Day 4and 8 in sleep deprivation on a 100 mm VAS(From Baseline to Day 4 and Day 8)
- Adverse events(From the start to end of study)
研究者
研究点 (10)
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