Clinical trial NCT03725085: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Subjects
Lead sponsor: Reckitt Benckiser LLC
Sponsor class: INDUSTRY
First posted: 2018-10-30
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

Patients were eligible for enrolment in the study if they fulfilled the following criteria:

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 (URTI) such as naso-pharyngitis
   * Sinusitis
3. Females of child bearing potential:

   1. 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\*.
   2. 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).
   3. Must have been non-lactating.
4. Patients must have demonstrated their willingness to participate in the study and comply with the study procedures and required visits.
5. Patients must have been willing to authorize use and disclosure of protected health information collected for the study.
6. Patients must have had the ability to understand and sign a written consent, which had to be signed prior to study specific procedures being performed.

   * \*Abstinence (sexually inactive) was not an acceptable form of contraception; however, abstinent female patients could have been admitted to the study if they agreed, and signed a statement to the effect, that upon becoming sexually active, they would use a condom with spermicide from that time through 30 days beyond completion of the study (Visit 2).

Exclusion Criteria:

Patients were excluded from the study if they fulfilled any of the following:

1. Females who were 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 Chronic Obstructive Pulmonary Disease (COPD) or cystic fibrosis (CF), etc.
4. Patients with known hypersensitivity to GGE.
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 had 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 were unable to comply fully with the study requirements.
10. Related to persons involved directly or indirectly with the conduct of this study \[i.e., investigator, sub-investigators, study coordinators, other study personnel, employees of Reckitt Benckiser or Ecron AcuNova Ltd. (EAL), formerly known as Manipal Acunova Limited (MAL) and the families of each\].

Primary outcomes:
measure: Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)
timeFrame: Up to Day 9
measure: Number of Subjects Affected With Adverse Events
timeFrame: Up to Day 9
measure: Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment
timeFrame: Up to Day 9
Secondary outcomes:
measure: Overall Assessment of the Study Medication by End of Study Patient Questionnaire
timeFrame: Up to Day 9
measure: Overall Assessment of the Study Medication by End of Study Investigator Questionnaire
timeFrame: Up to Day 9
Other outcomes:
Locations:
Study officials:
References:
citation: Tripathi S, Nikhare A, Sharma G, Shea T, Albrecht H. Safety And Tolerability Of Extended-Release Guaifenesin In Patients With Cough, Thickened Mucus And Chest Congestion Associated With Upper Respiratory Tract Infection. Drug Healthc Patient Saf. 2019 Oct 10;11:87-94. doi: 10.2147/DHPS.S222109. eCollection 2019.