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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 is a Phase 2 study that has completed, run by Reckitt Benckiser. The registered enrollment target is 2,810 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01537081
The ClinicalTrials.gov registry entry for NCT01537081 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 2,810 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Reckitt Benckiser, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01537081 reports 0 study locations.
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.
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