Ignite Creation Date:
2024-05-06 @ 1:35 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01842503
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2012-12-20
Brief Title:
Safety and Pharmacodynamic Study of GET 73 in Alcohol Dependent
Sponsor:
Laboratorio Farmaceutico Ct Srl
Organization:
Laboratorio Farmaceutico Ct Srl
Study Overview
Official Title:
A Phase 1b2a Cross-over Randomised Double-blind Placebo Controlled Study to Investigate the Safety and Pharmacodynamic Effects of GET 73 in Alcohol Dependent Subjects
Status:
COMPLETED
Status Verified Date:
2019-04
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:
SPAD
Brief Summary:
Examination of the effect of GET 73 on alcohol pharmacokinetics and pharmacodynamics intoxication and sedationand safety profile in alcohol-dependent individualsTo evaluate whether GET 73 as compared to placebo results in diminished cue-reactivity responses to alcohol cues in terms of urge to drink during the cue reactivity session and results in lower quantity of alcohol consumed during an alcohol self-administration session
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 |
|---|---|---|---|
| 2012-005515-13 | EUDRACT_NUMBER | None | None |