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Mucinex Exploratory Cold Study

Reckitt Benckiser logo

Reckitt Benckiser

Status and phase

Completed
Phase 2

Conditions

Common Cold

Treatments

Drug: guaifenesin (Mucinex)
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01046136
2009-MUC-03

Details and patient eligibility

About

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.

Enrollment

378 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

378 participants in 2 patient groups, including a placebo group

Mucinex
Active Comparator group
Treatment:
Drug: guaifenesin (Mucinex)
placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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