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
Condition: Healthy Subjects
Intervention: Mucinex™ extended-release (SE)
Intervention description: 2 tablets of Mucinex™ (GGE, 600 mg extended-release bi-layer tablets)
Intervention MeSH terms: Guaifenesin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 552.0
Sex: All
Minimum age: 18 Years
Maximum age: 82 Years
Healthy volunteers: Accepts Healthy Volunteers

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].