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NCT01537081 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
A Phase 2 study, sponsored by Reckitt Benckiser.
- Completed
- Registry status
- Phase 2
- Development phase
- 2,810
- Enrollment target
NCT01537081: Completed Phase 2 study, sponsored by Reckitt Benckiser.
NCT01537081 is a Phase 2 study that has completed, run by Reckitt Benckiser. The registered enrollment target is 2,810 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (2013% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01537081, a Phase 2 study, has completed, sponsored by Reckitt Benckiser.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2,810 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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 wit
Interventions
- DRUG Placebo
- DRUG Mucinex
- DRUG Immediate-release Guaifenesin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,810 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
What the finished NCT01537081 record still lists
NCT01537081 is an interventional study that assigns participants to a tested intervention. Its 2,810 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (2013% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01537081 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01537081 about?
NCT01537081 is a clinical study titled "Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections". 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 a...
What is the current status of trial NCT01537081?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,810 participants. The study started on 2011-09. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01537081?
The interventions under investigation include: Placebo (DRUG), Mucinex (DRUG), Immediate-release Guaifenesin (DRUG).
Who is sponsoring clinical trial NCT01537081?
This trial is sponsored by Reckitt Benckiser, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01537081's enrollment target sits among peer trials
2,810 6th of 2000 higher than 1,995 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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