Acute Upper Respiratory Tract InfectionPhase 2/3NCT01537081
Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
A Phase 2/3 study testing Mucinex and Immediate-release Guaifenesin in people with Acute Upper Respiratory Tract Infection, run by Reckitt Benckiser LLC at 43 sites in United States.
Trial summary
The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not match approved Mucinex labeling in the U.S. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Upper Respiratory Tract Infection
- What is being tested?
- Mucinex and Immediate-release Guaifenesin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,810 participants
- Where
- 43 sitesUnited States
- Study dates
- Sep 2011to Jul 2012
- Phase
- Phase 2/3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Has developed cold symptoms within 3 days prior to dosing on Day 1.
Who cannot join
- Chronic illnesses.
- Febrile illness > 101 F within 7 days prior to Day 1,
- Pregnant.
- Known current malignancy.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Reckitt Benckiser Study Site
Austin, Texas, 78705
Reckitt Benckiser Study Site
Bell Gardens, California, 90201
Reckitt Benckiser Study Site
Bellevue, Nebraska, 68005
Reckitt Benckiser Study Site
Brighton, Massachusetts, 02135
Reckitt Benckiser Study Site
Carrollton, Texas, 75010
Reckitt Benckiser Study Site
Chicago, Illinois, 60624
Reckitt Benckiser Study Site
Cincinnati, Ohio, 45246
Reckitt Benckiser Study Site
Colorado Springs, Colorado, 80907
Reckitt Benckiser Study Site
Dakota Dunes, South Dakota, 57049
Reckitt Benckiser Study Site
Daytona Beach, Florida, 32117
Reckitt Benckiser Study Site
Denver, Colorado, 80239
Reckitt Benckiser Study Site
Edgewater, Florida, 32132
Reckitt Benckiser Study Site
Fall River, Massachusetts, 02720
Reckitt Benckiser Study Site
Forth Worth, Texas, 76135
Reckitt Benckiser Study Site
Franklin, Tennessee, 37067
Reckitt Benckiser Study Site
Greer, South Carolina, 29651
Reckitt Benckiser Study Site
Harbor City, California, 90710
Reckitt Benckiser Study Site
Hoover, Alabama, 35216
Reckitt Benckiser Study Site
Jackson, Tennessee, 38305
Reckitt Benckiser Study Site
Largo, Florida, 33710
Reckitt Benckiser Study Site
Las Vegas, Nevada, 89102
Reckitt Benckiser Study Site
Las Vegas, Nevada, 89119
Reckitt Benckiser Study Site
Lexington, Kentucky, 40509
Reckitt Benckiser Study Site
Long Beach, California, 90813
Reckitt Benckiser Study Site
Metairie, Louisiana, 70006
Reckitt Benckiser Study Site
Middleburg Heights, Ohio, 44130
Reckitt Benckiser Study Site
New Orleans, Louisiana, 70115
Reckitt Benckiser Study Site
New Tazewell, Tennessee, 37825
Reckitt Benckiser Study Site
Normal, Illinois, 61761
Reckitt Benckiser Study Site
Omaha, Nebraska, 68114
Reckitt Benckiser Study Site
Omaha, Nebraska, 68134
Reckitt Benckiser Study Site
Raleigh, North Carolina, 27607
Reckitt Benckiser Study Site
Rochester, New York, 14609
Reckitt Benckiser Study Site
Sacramento, California, 95816
Reckitt Benckiser Study Site
Salt Lake City, Utah, 84124
Reckitt Benckiser Study Site
San Angelo, Texas, 76904
Reckitt Benckiser Study Site
San Francisco, California, 94102
Reckitt Benckiser Study Site
San Luis Obispo, California, 93405
Reckitt Benckiser Study Site
Smyrna, Tennessee, 37167
Reckitt Benckiser Study Site
Spokane, Washington, 99204
Reckitt Benckiser Study Site
Tomball, Texas, 77375
Reckitt Benckiser Study Site
Warwick, Rhode Island, 02886
Reckitt Benckiser Study Site
Wichita, Kansas, 67207
About this study
Official title: Randomized, Double-Blind, Double Dummy, Placebo-Controlled Study of the Safety and Efficacy Mucinex (2400 mg/d) and Immediate-Release Guaifenesin (800 mg/d) in the Treatment of Symptoms of Acute Upper Respiratory Tract Infections For 7 Days
The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not match approved Mucinex labeling in the U.S. The purpose of this study is to determine whether Mucinex is effective and non-inferior as compared to placebo and immediate release guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design was required based on EU regulatory guidance.
- Conditions
- Acute Upper Respiratory Tract Infection
- Being tested
- Mucinex, Immediate-release Guaifenesin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MucinexDrug
Also called Mucinex®, guaifenesin
Mucinex combines immediate-release (IR) and modified-release guaifenesin in a bilayer tablet. Each tablet was 600 mg of guaifenesin and taken by mouth with a full glass of water.
Immediate-release GuaifenesinDrug
Also called IR guaifenesin, IR GGE
Each tablet was 200 mg of immediate-release (IR) guaifenesin and taken by mouth with a full glass of water.
PlaceboDrug
Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water
| Study group | Role | What they receive |
|---|---|---|
| Mucinex 2400 mg/day | Experimental | The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600 mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet. Receives: Drug: Mucinex; Drug: Placebo |
| Immediate-release Guaifenesin 800 mg/Day | Active comparator | The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days. Receives: Drug: Immediate-release Guaifenesin; Drug: Placebo |
| Placebo | Placebo comparator | Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4
Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.
Measured: Day 4
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5
Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537081
- Sponsor's protocol ID
- 2011-MUC-04
- Status last verified
- Oct 2013
- First submitted
- 16 Feb 2012
- Last updated
- 14 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Double Dummy, Placebo-Controlled Study of the Safety and Efficacy Mucinex (2400 mg/d) and Immediate-Release Guaifenesin (800 mg/d) in the Treatment of Symptoms of Acute Upper Respiratory Tract Infections For 7 Days
- ClinicalTrials.gov ID
- NCT01537081
- Acronym / sponsor ID
- 2011-MUC-04
- Conditions
- Acute Upper Respiratory Tract Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,810 participants (actual)
- Lead sponsor
- Reckitt Benckiser LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Feb 2012 (estimated)
- Results
- Posted 12 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not match approved Mucinex labeling in the U.S. The purpose of this study is to determine whether Mucinex is effective and non-inferior as compared to placebo and immediate release guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design was required based on EU regulatory guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mucinex 2400 mg/day | Experimental | Drug: Mucinex, Drug: PlaceboThe study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600 mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet. |
| Immediate-release Guaifenesin 800 mg/Day | Active comparator | Drug: Immediate-release Guaifenesin, Drug: PlaceboThe dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboDouble dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Has developed cold symptoms within 3 days prior to dosing on Day 1.
Key exclusion criteria (4 listed)
- Chronic illnesses.
- Febrile illness > 101 F within 7 days prior to Day 1,
- Pregnant.
- Known current malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MucinexAlso: Mucinex®, guaifenesinMucinex combines immediate-release (IR) and modified-release guaifenesin in a bilayer tablet. Each tablet was 600 mg of guaifenesin and taken by mouth with a full glass of water. | Drug | Mucinex 2400 mg/day |
| Immediate-release GuaifenesinAlso: IR guaifenesin, IR GGEEach tablet was 200 mg of immediate-release (IR) guaifenesin and taken by mouth with a full glass of water. | Drug | Immediate-release Guaifenesin 800 mg/Day |
| PlaceboPlacebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water | Drug | Immediate-release Guaifenesin 800 mg/Day, Mucinex 2400 mg/day, Placebo |
Primary outcome
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4
Time frame: Day 4
Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5
Time frame: Day 5
Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mucinex and Immediate-release Guaifenesin in people with Acute Upper Respiratory Tract Infection, run by Reckitt Benckiser LLC at 43 sites in United States.
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 1 inclusion and 4 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 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 12 Sep 2013). 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?
Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4 (time frame: Day 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2013.