NCT03339726
Terminated
Phase 2
Randomized, Double-blind, Placebo-Controlled Study of the Efficacy of Phenylephrine HCL Extended-Release 30 mg and Phenylephrine HCL Immediate-Release 12 mg Capsules in Subjects With Nasal Congestion Due to the Common Cold
Johnson & Johnson Consumer Inc. (J&JCI)10 sites in 1 country193 target enrollmentNovember 30, 2017
ConditionsCommon Cold
Overview
- Phase
- Phase 2
- Intervention
- New Formulation Phenylephrine HCl
- Conditions
- Common Cold
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Enrollment
- 193
- Locations
- 10
- Primary Endpoint
- Mean Change From Baseline in the Nasal Congestion Severity Score
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
New Formulation Phenylephrine HCl
Intervention: New Formulation Phenylephrine HCl
Marketed Phenylephrine HCl
Intervention: Marketed Phenylephrine HCl
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Mean Change From Baseline in the Nasal Congestion Severity Score
Time Frame: 0-12 hours
Average change from baseline in the Nasal Congestion Severity Score on an 8 point scale with 0=None and 7=Severe. Change from baseline in the Nasal Congestion Severity Score averaged over assessments at 2, 4, 6, 8, 10, and 12 hours.
Secondary Outcomes
- Average Change From Baseline in the Nasal Congestion Severity Score(0-12 hours)
- Change From Baseline in the Nasal Congestion Severity Score(0-24 hours)
- Average Change From Baseline in Sinus Pressure/Tenderness Scores(0-12 hours)
- Change From Baseline in Sinus Pressure/Tenderness Scores(0-24 hours)
Study Sites (10)
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