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6 Trials

   

Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
dronabinol (VER-01) / Vertanical
2020-000107-36: Proof of efficacy, maintenance of efficacy, long-term safety andinvestigation of the potential for dependence and abuse and the effect ofabrupt drug withdrawal of VER-01 in a multicenter study in the treatmentof patients with chronic non-specific low back pain

Not yet recruiting
3
808
Europe
VER-01, Oral solution
Vertanical GmbH, Vertanical GmbH
For the treatment of patients with chronic non-specific low back pain when drug treatment is indicated and previous optimised treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance., Chronic Low Back Pain, Diseases [C] - Musculoskeletal Diseases [C05]
 
 
2022-001358-41: Clinical study to prove that treatment of chronic (non-specific) low back pain with VER-01, a cannabis based medicine, shows benefit compared to treatment with opioids

Not yet recruiting
3
350
Europe
Standardized oleoresin of Cannabis sativa L. folium cum flore, THC-chemotype, Tilidine and Naloxone (50 mg/4 mg) prolonged-release tablets, Tilidine and Naloxone (100 mg/8 mg) prolonged-release tablets, Tramadol 100 mg prolonged-release tablets, Tramadol 200 mg prolonged-release tablets, Fentanyl 12 micrograms/h transdermal patch, Fentanyl 25 micrograms/h transdermal patch, Fentanyl 50 micrograms/h transdermal patch, Oxycodone 5 mg prolonged-release tablets, Oxycodone 20 mg prolonged-release tablets, Oxycodone & Naloxone (5 mg/2.5 mg) prolonged-release tablets, Oxycodone & Naloxone (20 mg/10 mg) prolonged-release tablets, Hydromorphone 4 mg Prolonged Release tablets, Hydromorphone 8 mg Prolonged Release tablets, Morphine 10 mg prolonged-release tablets, Morphine 20 mg prolonged-release tablets, Tapentadol 50 mg prolonged-release tablets, Tapentadol 100 mg prolonged-release tablets, Buprenorphine 5 µg/h Transdermal Patch, Buprenorphine 15 µg/h Transdermal Patch, Buprenorphine 35 µg/h Transdermal Patch, VER-01, NA, Not Applicable, Oral solution, Prolonged-release tablet, Transdermal patch
Vertanical GmbH, Vertanical GmbH
Chronic non-specific low back pain, Back pain in between the lower edge of the ribs and the lower fold of the buttocks lasting for at least 3 months which has no specific identifiable cause, Diseases [C] - Musculoskeletal Diseases [C05]
 
 
NCT04940741 / 2020-000107-36: Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

Completed
3
820
Europe
VER-01, Placebo
Vertanical GmbH, Vertanical GmbH
Chronic Non-specific Low Back Pain
03/24
03/24
ELEVATE, NCT05610813: Comparison of VER-01 to Opioids in Patients With Chronic Non-specific Low Back Pain

Completed
3
384
Europe
VER-01, trans-Δ9-Tetra-hydrocannabinol (THC), Opioid therapy, Opioids
Vertanical GmbH
Chronic Non-specific Low Back Pain
10/24
10/24
EXPAND, NCT06956014: Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Low Back Pain

Not yet recruiting
3
700
NA
VER-01, Placebo
Vertanical GmbH
Chronic Low Back Pain
05/27
05/27
RESPONSE, NCT06475001: Dose-Response Characterization of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

Active, not recruiting
2
652
Europe
VER-01, Placebo
Vertanical GmbH
Chronic Non-specific Low Back Pain
08/25
08/25
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
dronabinol (VER-01) / Vertanical
2020-000107-36: Proof of efficacy, maintenance of efficacy, long-term safety andinvestigation of the potential for dependence and abuse and the effect ofabrupt drug withdrawal of VER-01 in a multicenter study in the treatmentof patients with chronic non-specific low back pain

Not yet recruiting
3
808
Europe
VER-01, Oral solution
Vertanical GmbH, Vertanical GmbH
For the treatment of patients with chronic non-specific low back pain when drug treatment is indicated and previous optimised treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance., Chronic Low Back Pain, Diseases [C] - Musculoskeletal Diseases [C05]
 
 
2022-001358-41: Clinical study to prove that treatment of chronic (non-specific) low back pain with VER-01, a cannabis based medicine, shows benefit compared to treatment with opioids

Not yet recruiting
3
350
Europe
Standardized oleoresin of Cannabis sativa L. folium cum flore, THC-chemotype, Tilidine and Naloxone (50 mg/4 mg) prolonged-release tablets, Tilidine and Naloxone (100 mg/8 mg) prolonged-release tablets, Tramadol 100 mg prolonged-release tablets, Tramadol 200 mg prolonged-release tablets, Fentanyl 12 micrograms/h transdermal patch, Fentanyl 25 micrograms/h transdermal patch, Fentanyl 50 micrograms/h transdermal patch, Oxycodone 5 mg prolonged-release tablets, Oxycodone 20 mg prolonged-release tablets, Oxycodone & Naloxone (5 mg/2.5 mg) prolonged-release tablets, Oxycodone & Naloxone (20 mg/10 mg) prolonged-release tablets, Hydromorphone 4 mg Prolonged Release tablets, Hydromorphone 8 mg Prolonged Release tablets, Morphine 10 mg prolonged-release tablets, Morphine 20 mg prolonged-release tablets, Tapentadol 50 mg prolonged-release tablets, Tapentadol 100 mg prolonged-release tablets, Buprenorphine 5 µg/h Transdermal Patch, Buprenorphine 15 µg/h Transdermal Patch, Buprenorphine 35 µg/h Transdermal Patch, VER-01, NA, Not Applicable, Oral solution, Prolonged-release tablet, Transdermal patch
Vertanical GmbH, Vertanical GmbH
Chronic non-specific low back pain, Back pain in between the lower edge of the ribs and the lower fold of the buttocks lasting for at least 3 months which has no specific identifiable cause, Diseases [C] - Musculoskeletal Diseases [C05]
 
 
NCT04940741 / 2020-000107-36: Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

Completed
3
820
Europe
VER-01, Placebo
Vertanical GmbH, Vertanical GmbH
Chronic Non-specific Low Back Pain
03/24
03/24
ELEVATE, NCT05610813: Comparison of VER-01 to Opioids in Patients With Chronic Non-specific Low Back Pain

Completed
3
384
Europe
VER-01, trans-Δ9-Tetra-hydrocannabinol (THC), Opioid therapy, Opioids
Vertanical GmbH
Chronic Non-specific Low Back Pain
10/24
10/24
EXPAND, NCT06956014: Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Low Back Pain

Not yet recruiting
3
700
NA
VER-01, Placebo
Vertanical GmbH
Chronic Low Back Pain
05/27
05/27
RESPONSE, NCT06475001: Dose-Response Characterization of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

Active, not recruiting
2
652
Europe
VER-01, Placebo
Vertanical GmbH
Chronic Non-specific Low Back Pain
08/25
08/25

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