Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03725085
Recruitment Status : Completed
First Posted : October 30, 2018
Results First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Mucinex™ extended-release (SE) Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 552 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : January 24, 2015
Actual Primary Completion Date : October 16, 2015
Actual Study Completion Date : October 16, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: 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

Drug: Mucinex™ extended-release (SE)
2 tablets of Mucinex™ (GGE, 600 mg extended-release bi-layer tablets)
Other Name: Guaifenesin bi-layer tablet




Primary Outcome Measures :
  1. 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


  2. 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

  3. 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 Outcome Measures :
  1. Overall Assessment of the Study Medication by End of Study Patient Questionnaire [ Time Frame: Up to Day 9 ]

    End of Study Patient Questionnaire is a questionnaire provided to the patients for overall assessment of the study medication at the end of study visit.

    Satisfied(stfd) Dissatisfied(Dstfd)


  2. Overall Assessment of the Study Medication by End of Study Investigator Questionnaire [ Time Frame: Up to Day 9 ]

    End of Study Investigator Questionnaire is a questionnaire provided at the end of study visit to the investigator (or sub-investigator as applicable) for overall assessment of the study medication across all patients treated by them.

    End of study investigator questionnaire was collected from 9 investigators.

    Mostly Satisfied(MS) Satisfied(Stfd) Very Satisfied(VS) Chest Congestion(CC) Chesty Cough(CCO) Difference(Diff) Between(b/w) Somewhat Agree(SA) Strongly Agree(StA) Upper respiratory tract infection(URTI) Optimal dosage(Opt dos) Cough preparations Available(CPA)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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].

Layout table for additonal information
Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT03725085     History of Changes
Other Study ID Numbers: 2012-MUC-PMS-IN
First Posted: October 30, 2018    Key Record Dates
Results First Posted: March 19, 2019
Last Update Posted: March 19, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Guaifenesin
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Expectorants
Respiratory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents