An Open Label, Multicentric Study to Evaluate the Safety and Tolerability of Mucinex™(Guaifenesin) 600 mg Extended-Release Bi- Layer Tablets in the Treatment of Otherwise Healthy Patients With Symptoms of Cough, Thickened Mucus and Chest Congestion
Overview
- Phase
- Phase 4
- Intervention
- Mucinex™ extended-release (SE)
- Conditions
- Healthy Subjects
- Sponsor
- Reckitt Benckiser LLC
- Enrollment
- 552
- Primary Endpoint
- Number of Subjects Affected With Adverse Events
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This was an open label, multicentric, non-comparative, single arm prospective post marketing surveillance (PMS) study to evaluate the safety and tolerability of Mucinex™ (GGE, 600 mg ER bi-layer tablets, taken as 1200 mg BID dose) in the treatment of otherwise healthy patients with symptoms of cough, thickened mucus and chest congestion due to URTI. Symptomatic patients who visited the outpatient department of hospitals and clinics or general physicians and had agreed to participate in this study were screened and enrolled into the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients were eligible for enrolment in the study if they fulfilled the following criteria:
- •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 (URTI) such as naso-pharyngitis
- •Sinusitis
- •Females of child bearing potential:
- •Must have used efficacious and reliable method of contraception during the entire duration of the study {e.g. double barrier methods (e.g., condom and spermicidal); intrauterine device (IUD) } or remained sexually inactive throughout the study\*.
- •Must have had a negative urine pregnancy test (UPT) at Screening/Baseline (test must have a sensitivity of at least 25 mIU/mL for HCG).
- •Must have been non-lactating.
Exclusion Criteria
- •Patients were excluded from the study if they fulfilled any of the following:
- •Females who were 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:
- •Chronic bronchitis
- •Emphysema
- •Other chronic pulmonary conditions such as Chronic Obstructive Pulmonary Disease (COPD) or cystic fibrosis (CF), etc.
- •Patients with known hypersensitivity to GGE.
- •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.
Arms & Interventions
Mucinex™ (GGE, 600 mg extended-release bi-layer tablets)
2 tablets of Mucinex™ (GGE, 600 mg ER bi-layer tablets, taken as 1200 mg BID dose) every 12 hours (twice daily, in the morning and the evening) orally with a full glass of water for 7 days. GGE = Guaifenesin BID = Twice in a day
Intervention: Mucinex™ extended-release (SE)
Outcomes
Primary Outcomes
Number of Subjects Affected With Adverse Events
Time Frame: Up to Day 9
Proportion of patients with AE(s) - Number of Subjects affected with Events
Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)
Time Frame: Up to Day 9
Treatment Emergent Adverse Event (TEAE) are events occurring after the first dose of study medication. Frequency of AE(s) - the total Number of Events Type of AE(s) - Serious TEAE and Non serious TEAE
Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
Time Frame: Up to Day 9
Intensity determined. Mild = AE did not limit usual activities; subject may have experienced slight discomfort. Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort. Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain. Relationship to Investigational Medicinal Products (IMP) Unassessable/Unclassified = Insufficient information to be able to make an assessment Conditional/ Unclassified = Insufficient information to make an assessment at present Unrelated = No possibility that the AE was caused by the IMP Unlikely = Slight, but remote, chance that the AE was caused by the IMP, but the balance of judgment was that it was most likely not due to the IMP. Possible = Reasonable suspicion that the AE was caused by the IMP Probable = Most likely that the AE was caused by the IMP Certain = AE was definitely caused by the IMP
Secondary Outcomes
- Overall Assessment of the Study Medication by End of Study Patient Questionnaire(Up to Day 9)
- Overall Assessment of the Study Medication by End of Study Investigator Questionnaire(Up to Day 9)