MucinexTM (Guaifenesin) 600 mg Extended-Release Bi-Layer Tablets Safety and Tolerability Post Marketing Surveillance Study
- Conditions
- Health Condition 1: null- Symptoms of Cough, Thickened Mucus and Chest Congestion
- Registration Number
- CTRI/2014/07/004730
- Lead Sponsor
- Reckitt Benckiser LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 650
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.
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:
Asthma
Chronic bronchitis
Emphysema
Other chronic pulmonary conditions such as COPD or cystic fibrosis
(CF), etc.
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).
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method