NCT03339726

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-11-30
• Primary completion: 2018-04-16
• Completion: 2018-04-16
• First posted: 2017-11-13
• Last updated: 2019-06-04
• Results posted: 2019-06-04

Locations

11 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study