Ignite Creation Date:
2024-05-06 @ 3:15 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02246166
Status:
COMPLETED
Last Update Posted:
2016-09-14
First Post:
2014-09-18
Brief Title:
The Effect of Paracetamol Pseudoephedrine Hydrochloride Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Double-Blind Randomised Placebo-Controlled Parallelgroup Single-Dose Study to Evaluate Effect of Paracetamol Pseudoephedrine Hydrochloride Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza Over a 4 Hour Period
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IV multi-centre randomised double-blind placebo-controlled parallel-group single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza Eligible participants will be randomly assigned to one of 2 treatment groups active or placebo tablets and enter a four-hour hr treatment phase Each participant will be administered only once during each study period Participants will use a questionnaire to record the symptom severity scores as described as well as time
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RH02565 | OTHER | GSK | None |