Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533657
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Unique Treatment of Oncology Pain in Advanced Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2A Study to Investigate the Safety and Preliminary Analgesic Efficacy of Oral Trichomylin in Male and Female Participants 18 Years of Age and Above With Advanced Cancer and Moderate to Severe Cancer-Related Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UTOPIA-1
Brief Summary:
This will be a proof-of-concept single arm study with a maximum of 20 patients to evaluate preliminary analgesic efficacy and safety of Trichomylin in patients with advanced cancer male and female who suffer from moderate to severe chronic pain and who are taking a stable dose of long-acting opioid therapy for at least 1 week prior to screening
Detailed Description:
This study will consist of a screening visit treatment and safety follow-up period There will be an initial patient determined titration phase using escalated doses of Investigational Product to reach a dose that achieves symptom relief with tolerable side effects Each capsule of Trichomylin contains a fixed ratio of 5 mg delta-9-tetrahydrocannabinol 5 mg cannabidiol 5 mg cannabichromene Participants can titrate up to a maximum of 2 capsules twice daily total of 4 capsules This will be followed by a 5 day assessment period of the stable dose determined in collaboration with clinicians
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