Ignite Creation Date:
2024-05-06 @ 12:52 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03865953
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2019-03-02
Brief Title:
Oral LAT8881 in Neuropathic Pain
Sponsor:
Lateral Pharma Pty Ltd
Organization:
Lateral Pharma Pty Ltd
Study Overview
Official Title:
A Phase IIa Study of the Efficacy and Safety of Oral LAT8881 in Neuropathic Pain
Status:
COMPLETED
Status Verified Date:
2021-04
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:
None
Brief Summary:
This is a randomised placebo-controlled double-blind crossover phase IIa study to investigate the efficacy and safety of oral LAT8881 in neuropathic pain
Detailed Description:
This is a randomised placebo-controlled double-blind crossover phase IIa study to investigate the efficacy and safety of oral LAT8881 in neuropathic pain After a one week baseline period subjects entered into the study will be randomised to receive Investigational Medicinal Product IMP LAT8881 or placebo twice daily for four weeks
The first treatment period will be followed by a washout period of two weeks and then a second baseline period of one week Subjects will not take any IMP over these three weeks
After the second baseline period subjects will cross over to receive the second treatment either LAT8881 or placebo whichever treatment was not received in the first treatment period twice daily for four weeks
The pharmacokinetics PK of LAT8881 will be investigated in 15 subjects PK subjects at selected Australian sites
The first treatment period will be followed by a washout period of two weeks and then a second baseline period of one week Subjects will not take any IMP over these three weeks
After the second baseline period subjects will cross over to receive the second treatment either LAT8881 or placebo whichever treatment was not received in the first treatment period twice daily for four weeks
The pharmacokinetics PK of LAT8881 will be investigated in 15 subjects PK subjects at selected Australian sites
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-004534-15 | EUDRACT_NUMBER | None | None |