CTRI/2014/07/004730已完成Unknown
An Open Label, Multicentric Study to Evaluate the Safety and Tolerability of MucinexTM (Guaifenesin) 600 mg Extended-Release Bi-Layer Tablets in the Treatment of Otherwise Healthy Patients With Symptoms of Cough, Thickened Mucus and Chest Congestion
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 9
- 主要终点
- 1. The number of AE(s), type of AE(s), frequency of AE(s) and proportion of patients with AE(s).
研究概览
简要总结
This is an open label, multicentric, non-comparative, single arm prospective post marketing surveillance study to evaluate the safety and tolerability of MucinexTM (Guaifenesin, 600 mg extended-release bi-layer tablets in the treatment of otherwise healthy patients with symptoms of cough, thickened mucus and chest congestion due to upper respiratory tract infection (URTI).
Symptomatic patients coming to the outpatient department of hospitals and clinics or to general physicians who have agreed to participate in this study will be screened and enrolled into the study.
A total of 650 patients will be enrolled in the study in order to derive approximately 550 (completers) evaluable patients.
Screened: 554 patients
Enrolled: 552 patients
Completed: 550 patients
Study has been closed now. Last site close-out performed on 23-Feb-2016.
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
- •Only patients who meet all of the following criteria will be enrolled
- •Males and females (non-pregnant) patients of > 18 years of age.
- •Otherwise healthy patients suffering from cough with symptoms of thickened mucus and chest congestion and a diagnosis of any one of the following: Acute Bronchitis, Upper respiratory tract infections such as naso-pharyngitis and Sinusitis
- •Females of child bearing potential a.
- •Must use efficacious and reliable method of contraception during the entire duration of the study {e.g. double barrier methods (e.g condom and spermicidal); IUD} or remain sexually inactive throughout the study.[Abstinence (sexually inactive) is not an acceptable form of contraception; however, abstinent female subjects will be admitted to the study if they agree, and have signed a statement to the effect, that upon becoming sexually active, will use a condom with spermicide from that time through 30 days beyond completion of the study (Visit 2)] b.
- •Must have a negative urine pregnancy test (UPT) at Screening/Baseline (test must have a sensitivity of at least 25 mIU/mL for HCG).
- •Must be non-lactating.
- •Patients must demonstrate their willingness to participate in the study and comply with the study procedures and required visits.
- •Patients must be willing to authorize use and disclosure of protected health information collected for the study.
- •Patients must have the ability to understand and sign a written consent, which must be signed prior to study specific procedures being performed.
排除标准
- •Patients who meet any of the following criteria will be excluded:
- •Females who are pregnant or lactating or planning to become pregnant during the study period.
- •Patients with a history of chronic cough of 3 weeks duration.
- •Patients with any of the following conditions: Asthma Chronic bronchitis Emphysema Other chronic pulmonary conditions such as COPD or cystic fibrosis (CF), etc.
- •Patients with known hypersensitivity to guaifenesin.
- •Patients with temperature greater than 101°F (38.3°C) at Screening/Baseline.
- •Patients with a serious and/or uncontrolled medical condition (chronic or active liver disease, renal impairment, heart disease, diabetes, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions or any other disease) that in the opinion of the Investigator would interfere with the study or place the patient at unacceptable risk.
- •Patients with a history or examination findings of alcohol dependence, alcohol or drug abuse or suspected abuse within the past 2 years.
- •Patients who have participated in a study of an investigational drug within 30 days prior to the Screening/Baseline visit.
- •Patients who in the opinion of the Investigator are unable to comply fully with the study requirements.
- •Related to persons involved directly or indirectly with the conduct of this study (i.e., Investigator, Sub-Investigators, Study Coordinators, other study personnel, employees of Reckitt Benckiser or Manipal AcuNova Ltd.
- •(MAL) and the families of each).
结局指标
主要结局
1. The number of AE(s), type of AE(s), frequency of AE(s) and proportion of patients with AE(s).
时间窗: 7 to 9 days
2. The severity, seriousness and the relationship of AE(s) to treatment
时间窗: 7 to 9 days
次要结局
- 1. End of Study Patient Questionnaire(2. End of Study Investigator Questionnaire)
研究者
研究点 (9)
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