AN OBSERVATIONAL, PRESCRIBER BASED, MULTICENTRIC,POST MARKETING SURVEILLANCE STUDY (PMS) TO GENERATESAFETY & EFFICACY DATA OF FIXED DOSE COMBINATION(FDC) OF CODEINE PHOSPHATE 10mg & CHLORPHENIRAMINEMALEATE 4mg PER 5ml ORAL SYRUP FOR MANAGEMENT OFSYMPTOMS OF DRY COUGH IN ADULT PATIENTS.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Adverse Events, Serious Adverse Events, Unexpected Adverse Events, Adverse Drug Reactions and Treatment Emergent Adverse Events.
研究概览
简要总结
This is a prospective, single arm, multi-center, open-label, prescriber based, observational Post Market Surveillance study in Indian adult subjects who have symptoms of cough associated with upper respiratory allergies or common cold aged 18 years or older. The current study will aim to evaluate the safety and efficacy of fixed dose combination of Codeine Phosphate 10mg & Chlorpheniramine Maleate 4mg per 5ml oral syrup in the actual field conditions for the management of symptoms of cough associated with upper respiratory allergies or common cold.
The duration of individual participation will be approximately 7 days (7 days treatment period).
Key safety assessments include : Adverse Events (AEs), Serious Adverse Events (SAEs), Unexpected Adverse Events, Adverse Drug Reactions.
Key efficacy assessments include : Change in the cough severity (daily) and frequency (daily) score assessed during follow-up visit at Day 3 and Day 7 or up to complete recovery (whichever is earlier) compared to the baseline, Number of awakenings in the night due to cough (24 hours) assessed during follow-up visit, Time taken for complete cough relief (days) assessed during follow-up visit, Change in score of throat pain and throat irritation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male & female (non-pregnant, non-lactating, post-menopausal, surgically sterilized or practicing a reliable method of birth control during the duration of study) Subjects with age ranging from 18 to 65 years (both inclusive).
- •Subjects having dry cough (less than 7 days) of any origin and may be with related symptoms as Throat Pain, throat redness, Throat irritation/itching, (Fever if present) (absence of bronchial mucus/phlegm production).
- •Not under any antibacterial or antiviral treatment before recruitment.
- •Subjects ready to abstain from using any drug (which will affect the study outcome) other than Investigational Product for the treatment of the study condition during the study period (except in cases when patient’s condition worsens as per study physician.
- •In this case, Study physician will decide to prescribe antibiotic, if required).
- •Ready to abstain from the administration of any herbal or ayurvedic treatment or gargles directed to ease coughing or throat parameters.
- •Willing to provide written informed consent 7.
排除标准
- •Subjects with known allergy or hypersensitivity to Codeine Phosphate or Chlorpheniramine Maleate or any of its components.
- •Subjects who had taken any medicated confectionary, throat pastille, spray or any product with demulcent properties, any cough medicines or drugs containing antihistamines within last 24 hours prior to screening.
- •Subjects taking medications with known cough promoting side effects (e.g., angiotensin converting enzyme inhibitors or angiotensin II receptor blockers) that in the opinion of the investigator are causing symptoms of cough.
- •Subjects with diagnosis of diseases of pneumonia, asthma, sinusitis, allergic rhinitis, as well as heart disease.
- •Severe cough requiring hospitalization
- •Subjects who had used any local anesthetic within the past 24 hours.
- •Subjects who have used a longer acting or slow release analgesic during the previous 24 hours.
- •Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease
- •Any other condition, which in the opinion of the clinician/investigator, could interfere significantly with the treatment and assessment process
- •Use of any investigational therapy within 30 days prior to randomization.
结局指标
主要结局
Adverse Events, Serious Adverse Events, Unexpected Adverse Events, Adverse Drug Reactions and Treatment Emergent Adverse Events.
时间窗: 7 Days
次要结局
- Number of awakenings in the night due to cough (24 hours) assessed during follow-up visit(Day 7)
- Time taken for complete cough relief (days) assessed during follow-up visit(Day 7)
- Change in the cough severity( daily) and frequency (daily) score assessed during(follow-up visit at Day 3 and Day 7 or up to complete recovery (whichever is)
- Change in score of throat pain and throat irritation(Day 7)