Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490445
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-30
Brief Title:
A Study of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain DPNP
Sponsor:
Syqe Medical
Organization:
Syqe Medical
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled 4-arm Parallel-group Multiple-Dose Study to Assess Efficacy and Safety of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The primary purpose of this study is to evaluate the efficacy of medical cannabis aerosol containing 025 05 10 milligrams mg delta Δ9-tetrahydrocannabinol THC inhaled three times a day TID compared to placebo via the Fixed-dose Syqe Inhaler on pain intensity at Week 15
Detailed Description:
This study will assess the efficacy safety tolerability and pharmacokinetics PK of medical cannabis aerosol inhaled via the Syqe Inhaler at nominal doses of 0 placebo 025 05 and 10 mg TID of Δ9-THC added on to standard of care for treatment of DPNP
The target sample size is 192 eligible participants worldwide randomized from up to approximately 51 recruiting sites in up to approximately 8 countries
The study consists of 1 a screening period of up to 14 days 2 a 15-week parallel-group randomized double-blind treatment period including a 3-week up-titration period and a 12-week maintenance period and 3 a post-treatment safety follow-up period of 4 weeks
The target sample size is 192 eligible participants worldwide randomized from up to approximately 51 recruiting sites in up to approximately 8 countries
The study consists of 1 a screening period of up to 14 days 2 a 15-week parallel-group randomized double-blind treatment period including a 3-week up-titration period and a 12-week maintenance period and 3 a post-treatment safety follow-up period of 4 weeks
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508932-68-00 | CTIS | None | None |