AzTrials
AzTrials

Healthy SubjectsPhase 4NCT03725085

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

A Phase 4 study testing Mucinex™ extended-release (SE) in people with Healthy Subjects, run by Reckitt Benckiser LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 82 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
Mucinex™ extended-release (SE)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
552 participants
Where
No sites listed yet
Study dates
24 Jan 2015to 16 Oct 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 82 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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.
  • Patients must have demonstrated their willingness to participate in the study and comply with the study procedures and required visits.
  • Patients must have been willing to authorize use and disclosure of protected health information collected for the study.
  • 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).

Who cannot join

  • 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:
  • Asthma
  • Chronic bronchitis
Show all 15Show fewer
  • 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.
  • Patients with a history or examination findings of alcohol dependence, alcohol or drug abuse or suspected abuse within the past 2 years.
  • Patients who had participated in a study of an investigational drug within 30 days prior to the Screening/Baseline visit.
  • Patients who in the opinion of the investigator were unable to comply fully with the study requirements.
  • 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].

About this study

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

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.

Being tested
Mucinex™ extended-release (SE)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mucinex™ extended-release (SE)Drug

    Also called Guaifenesin bi-layer tablet

    2 tablets of Mucinex™ (GGE, 600 mg extended-release bi-layer tablets)

Study groups in NCT03725085
Study groupRoleWhat they receive
Mucinex™ (GGE, 600 mg extended-release bi-layer tablets)Experimental2 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
Receives: Drug: Mucinex™ extended-release (SE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)

    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

    Measured: Up to Day 9

  2. Number of Subjects Affected With Adverse Events

    Proportion of patients with AE(s) - Number of Subjects affected with Events

    Measured: Up to Day 9

  3. Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment

    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

    Measured: Up to Day 9

Secondary outcomes (2)

  1. Overall Assessment of the Study Medication by End of Study Patient Questionnaire

    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)

    Measured: Up to Day 9

  2. Overall Assessment of the Study Medication by End of Study Investigator Questionnaire

    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)

    Measured: Up to Day 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2018
  2. Study start24 Jan 2015
  3. Primary completion16 Oct 2015
  4. Study completion16 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
552 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03725085
Sponsor's protocol ID
2012-MUC-PMS-IN
Status last verified
Feb 2019
First submitted
29 Oct 2018
Last updated
19 Mar 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 31632154

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mucinex™ extended-release (SE) in people with Healthy Subjects, run by Reckitt Benckiser LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s) (time frame: Up to Day 9). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03725085, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in