NCT04610047

Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness

A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of Norketotifen (NKT) in the Treatment of Acute Uncomplicated Influenza-like Illness (ILI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Emergo Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b, multi-center, double-blind, randomized, placebo-controlled, parallel-group study of NKT versus placebo in otherwise healthy adults presenting with acute uncomplicated ILI due to influenza or other respiratory viruses in a community setting.

Conditions

• Influenza
• Influenza -Like Illness

Interventions

Type	Name	Description
DRUG	Norketotifen	Oral capsule
DRUG	Placebo	Oral capsule

Timeline

• Start date: 2020-12-14
• Primary completion: 2022-01-25
• Completion: 2022-02-09
• First posted: 2020-10-30
• Last updated: 2023-01-30

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study