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Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold

NCT03339726 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2019-06-04

Study results available
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Summary

This will be a randomized, double-blind, placebo controlled, parallel-group Phase 2 study to evaluate the efficacy of a new formulation of phenylephrine HCl and a currently marketed phenylephrine HCl for relief of nasal congestion in subjects with naturally occurring cold symptoms.

Conditions

  • Common Cold

Interventions

DRUG

New Formulation Phenylephrine HCl

2 doses of one tablet 12 hours apart

DRUG

Marketed Phenylephrine HCl

4 doses of one capsule 4 hours apart

DRUG

Placebo

4 doses of placebo capsule and tablet taken 4 hours apart

Sponsors & Collaborators

  • Johnson & Johnson Consumer Inc. (J&JCI)

    lead INDUSTRY

Principal Investigators

  • Steve Sacavage · Johnson and Johnson Consumer, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2018-04-16
Completion
2018-04-16
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03339726 on ClinicalTrials.gov