Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230230
Status:
COMPLETED
Last Update Posted:
2015-09-16
First Post:
2005-09-22
Brief Title:
Comparison of SCH 486757 to Codeine and Placebo in Subjects With Persistent Postviral Cough Study P03069AM2COMPLETED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
SCH 486757 vs Codeine and Placebo in Subjects With Persistent Postviral Cough
Status:
COMPLETED
Status Verified Date:
2015-09
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 randomized multicenter parallel-group double-blind double-dummy placebo- and active-controlled study will evaluate the efficacy and safety of SCH 486757 in subjects with persistent cough resulting from a recent viral upper respiratory infection URI The primary objective is to assess the efficacy of SCH 486757 administered at a dose of 100 mg twice daily for 5 days in the reduction of cough severity score compared with placebo The key secondary objective is to evaluate the reduction in the number of coughs with SCH 486757 compared with placebo Because codeine is a widely used as a cough medication it is included as a treatment arm in the study
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