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

Phase 2

Terminated

• Conditions: Common Cold
• Interventions: Drug: Marketed Phenylephrine HCl; Drug: New Formulation Phenylephrine HCl; Drug: Placebo

• Registration Number: NCT03339726
• Lead Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Study Start: 2017-11-30
• Primary Completion: 2018-04-16
• Study Completion: 2018-04-16
• Results First Submitted: 2019-04-16
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-03
• Last Update Submitted: 2019-06-03
• Results First Posted: 2019-06-04
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Marketed Phenylephrine HCl	Marketed Phenylephrine HCl	-
New Formulation Phenylephrine HCl	New Formulation Phenylephrine HCl	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in the Nasal Congestion Severity Score	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 Outcome Measures

Name	Time	Method
Average Change From Baseline in the Nasal Congestion Severity Score	0-12 hours	Average change from baseline in the Nasal Congestion Severity Score averaged over hours 8-12. This is an 8 point scale with 0=None and 7=Severe.
Change From Baseline in the Nasal Congestion Severity Score	0-24 hours	Change from baseline in the Nasal Congestion Severity Score at 24 hours. This is an 8 point scale with 0=None and 7=Severe.
Average Change From Baseline in Sinus Pressure/Tenderness Scores	0-12 hours	Change from baseline in Sinus Pressure/Tenderness Scores averaged over assessments at 2, 4, 6, 8, 10, and 12 hours. This is an 8 point scale with 0=None and 7=Severe.
Change From Baseline in Sinus Pressure/Tenderness Scores	0-24 hours	Change from baseline in Sinus Pressure/Tenderness Scores at 24 hours. This is an 8 point scale with 0=None and 7=Severe.

Trial Locations

Locations (10)

The Medical Arts Health Research Group; 🇨🇦 Kelowna, British Columbia, Canada

Sunningdale Health and Wellness Centre; 🇨🇦 London, Ontario, Canada

Dawson Road Family Medical Clinic; 🇨🇦 Guelph, Ontario, Canada

PrimeHealth Clinical Research; 🇨🇦 Toronto, Ontario, Canada

James Lai, MD, Inc; 🇨🇦 Vancouver, British Columbia, Canada

Diex Recherche; 🇨🇦 Victoriaville, Quebec, Canada

Canadian Phase Onward, Inc.; 🇨🇦 Toronto, Ontario, Canada

NEOMO Research; 🇨🇦 Sudbury, Ontario, Canada

Bluewater Clinical Research Group, Inc.; 🇨🇦 Sarnia, Ontario, Canada

Mission Hills Urgent Care Walk in Clinic; 🇨🇦 Mission, British Columbia, Canada