Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05766969
Status:
UNKNOWN
Last Update Posted:
2023-03-13
First Post:
2023-03-02
Brief Title:
Diabetic Neuropathic Pain Relief 6 Weeks Dosage Sublingual Water-soluble CBDPEA
Sponsor:
Pure Green Pharmaceuticals Inc
Organization:
Pure Green Pharmaceuticals Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Trial Using Cannabidiol and Palmitoylethanolamide for the Treatment of Painful Diabetic Peripheral Neuropathy of the Feet
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
NOT_YET_RECRUITING
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:
The purpose of the study is to evaluate whether the DIANPR-6 is a better pain reliever in patients with diabetic neuropathic pain of the feet compared to placebo
Detailed Description:
Subjects will be enrolled in the study for a maximum of 63 days including an optional 14-day screening period 42 days of active product administration and followed by post-treatment blood work EKG and questionnaires within 24-hours following study treatment completion and a psychiatric and primary health care provider evaluation within 1 week of trial completion
The primary objective of this study is
To evaluate the impact of PGP-010-50-1 on subjects painful diabetic neuropathic pain pDNP anxiety and sleep quality compared to a placebo control
To evaluate the impact of PGP-010-50-1 on the subjects impression of their response to the treatment compared to a placebo control
The secondary objectives of this study are
To evaluate the safety of PGP-010-50-1 for the treatment of painful diabetic peripheral neuropathy DPN of the feet compared to a placebo control
To evaluate PGP-010-50-1 on liver function
To evaluate PGP-010-50-1 on Hbg A1C
The primary objective of this study is
To evaluate the impact of PGP-010-50-1 on subjects painful diabetic neuropathic pain pDNP anxiety and sleep quality compared to a placebo control
To evaluate the impact of PGP-010-50-1 on the subjects impression of their response to the treatment compared to a placebo control
The secondary objectives of this study are
To evaluate the safety of PGP-010-50-1 for the treatment of painful diabetic peripheral neuropathy DPN of the feet compared to a placebo control
To evaluate PGP-010-50-1 on liver function
To evaluate PGP-010-50-1 on Hbg A1C
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?:
None
Is an FDA AA801 Violation?:
None