NCT03005067

To Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Participants With Symptoms of Common Cold

A Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Subjects With Symptoms of Common Cold

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted in adult participants with symptoms of common cold assessing if 1146A nasal spray reduces the severity of symptoms of the common cold compared to placebo. The study will also evaluate the safety of 1146A compared to placebo.

Detailed description

This will be a multi-center, randomized, parallel-group, double blind, 2-arm, placebo controlled study to evaluate the efficacy and safety of 1146A in adult participants with symptomatic common cold in an outpatient setting.

Conditions

• Common Cold

Interventions

Type	Name	Description
DRUG	Carbomer 980 (1146A)	Test product containing carbomer 980 gel
OTHER	Placebo	Reference product containing vehicle without carbomer 980 gel

Timeline

• Start date: 2016-12-29
• Primary completion: 2017-06-07
• Completion: 2017-06-07
• First posted: 2016-12-29
• Last updated: 2018-06-19
• Results posted: 2018-06-19

Locations

24 sites across 1 country: United States