CTRI/2014/07/004730已完成4 期
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 - Nil
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Only patients who meet all of the following criteria will be enrolled
- •1. Males and females (non-pregnant) patients of > 18 years of age.
- •2. 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
- •3. 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).
- •c. Must be non-lactating.
- •4. Patients must demonstrate their willingness to participate in the study and comply with the study procedures and required visits.
- •5. Patients must be willing to authorize use and disclosure of protected health information collected for the study.
- •6. 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:
- •1. Females who are pregnant or lactating or planning to become pregnant during
- •the study period.
- •2. Patients with a history of chronic cough of 3 weeks duration.
- •3. Patients with any of the following conditions:
- •Chronic bronchitis
- •Other chronic pulmonary conditions such as COPD or cystic fibrosis
- •4. Patients with known hypersensitivity to guaifenesin.
- •5. Patients with temperature greater than 101°F (38.3°C) at Screening/Baseline.
- •6. 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.
- •7. Patients with a history or examination findings of alcohol dependence, alcohol
- •or drug abuse or suspected abuse within the past 2 years.
- •8. Patients who have participated in a study of an investigational drug within 30
- •days prior to the Screening/Baseline visit.
- •9. Patients who in the opinion of the Investigator are unable to comply fully with
- •the study requirements.
- •10. 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).
研究者
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