Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT02678234
Status:
WITHDRAWN
Last Update Posted:
2018-03-12
First Post:
2016-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy and Safety Study of Theraflu Day Powder as Oral Solution for Cold and Flu
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The clinical phase of the study (from FSFV to LSLV) was never initiated due to the sponsor's decision.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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".
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: