NCT02678234

An Efficacy and Safety Study of Theraflu Day Powder as Oral Solution for Cold and Flu

An Open-label, Multicenter, Randomized, Parallel Group, Single-dose Study to Assess the Short Term Efficacy and Safety of Paracetamol 500 mg + Phenylephrine HCl 10 mg + Vitamin C 200 mg Powder for Oral Solution in Subjects With Symptoms of an Upper Respiratory Tract Infection

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the short term efficacy of the Theraflu Aktiv powder for oral solution in the Russian population as compared to an untreated group to support the indication of "Short term relief of the symptoms of colds, chills and influenza, including mild to moderate pain, fever and nasal congestion".

Conditions

• Infections, Respiratory Tract

Interventions

Type	Name	Description
DRUG	Paracetamol, phenylephrine HCl, and vitamin C	One sachet is provided for each participant randomized to the Theraflu Aktiv powder for oral solution

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2016-02-09
• Last updated: 2018-03-12