Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT04647435
Status:
COMPLETED
Last Update Posted:
2025-02-07
First Post:
2020-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction
Sponsor:
Apsen Farmaceutica S.A.
Organization:
Study Overview
Official Title:
National, Multicentre, Randomized, Double-blind, Triple-dummy Active-Controled Phase III Clinical Trial to Evaluate the Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction.
Status:
COMPLETED
Status Verified Date:
2025-02
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:
CARLOTA
Brief Summary:
The purpose of this study is to evaluate the efficacy of APSCTC compared to two active drugs in acute pain relief.
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?:
False
Is an FDA AA801 Violation?: