NCT01046136

Brief Summary

This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
378

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 7, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

August 24, 2012

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

January 7, 2010

Results QC Date

March 3, 2011

Last Update Submit

December 3, 2020

Conditions

Common Cold

Keywords

common cold

Outcome Measures

Primary Outcomes (2)

  • Investigator's End of Study Assessment of Treatment

    Yes the investigator would use this treatment for cold symptoms in the future.

    7 days

  • Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough.

    Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough.

    Baseline and Day 4

Secondary Outcomes (1)

  • Number of Patients With Adverse Events

    7 days

Study Arms (2)

Mucinex

ACTIVE COMPARATOR
Drug: guaifenesin (Mucinex)

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

guaifenesin (Mucinex)DRUG

bid 7 days

Mucinex
placeboDRUG

bid 7 days

placebo

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • common cold symptoms
  • meet symptom severity
  • females of child-bearing potential must have negative pregnancy test and use effective birth control

You may not qualify if:

  • chronic respiratory conditions
  • significant heart, kidney, liver, or lung disease, uncontrolled hypertension or diabetes, cystic fibrosis, thyroid disorder
  • pregnant or lactating
  • known malignancy
  • participation in any other clinical trial within 30 days of baseline
  • related to another enrolled patient or persons involved directly or indirectly with the conduct of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pioneer Clinical Research

Bellevue, Nebraska, 68005, United States

Location

Related Publications (2)

  • Hoffer-Schaefer A, Rozycki HJ, Yopp MA, Rubin BK. Guaifenesin has no effect on sputum volume or sputum properties in adolescents and adults with acute respiratory tract infections. Respir Care. 2014 May;59(5):631-6. doi: 10.4187/respcare.02640. Epub 2013 Sep 3.

    PMID: 24003241DERIVED

  • Albrecht H, Vernon M, Solomon G. Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms. Respir Res. 2012 Dec 27;13(1):118. doi: 10.1186/1465-9921-13-118.

    PMID: 23270519DERIVED

MeSH Terms

Conditions

Common Cold

Interventions

GuaifenesinAcetylcysteine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuaiacolMethyl EthersEthersOrganic ChemicalsPhenyl EthersCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCysteineAmino Acids, SulfurSulfur CompoundsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Kim Clark
Organization
Reckitt Benckiser
ClinicalRequests@rb.com
855.966.5483

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2010

First Posted

January 11, 2010

Study Start

December 1, 2009

Primary Completion

March 1, 2010

Last Updated

December 30, 2020

Results First Posted

August 24, 2012

Record last verified: 2020-12

Locations

US(1)