Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475001
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-12
Brief Title:
Dose-Response Characterization of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain
Sponsor:
Vertanical GmbH
Organization:
Vertanical GmbH
Study Overview
Official Title:
Multicenter Double-blind Randomized Placebo-controlled Dose Response Trial With the Full-spectrum Cannabis Extract VER-01 in Patients With Chronic Non-specific Low Back Pain
Status:
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:
RESPONSE
Brief Summary:
Dose-response characterization of VER-01 in patients with chronic non-specific low back pain CLBP for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance
Detailed Description:
The primary objective of this multicenter double-blind randomized placebo-controlled trial is to characterize the dose-response relationship of VER-01 in terms of pain reduction in patients with chronic non-specific low back pain
Eligible patients are randomized to one of four different dose groups cohorts in a 1111 ratio and either active drug VER-01 or placebo
The secondary objectives are to evaluate the efficacy using additional outcome measures the safety and the tolerability of VER-01 compared to placebo
Eligible patients are randomized to one of four different dose groups cohorts in a 1111 ratio and either active drug VER-01 or placebo
The secondary objectives are to evaluate the efficacy using additional outcome measures the safety and the tolerability of VER-01 compared to placebo
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 |
|---|---|---|---|
| 2023-507358-34 | EUDRACT_NUMBER | None | None |
| 1008617 | OTHER | None | None |