DRONABINOL ( DrugBank: Dronabinol )


5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症1
13多発性硬化症/視神経脊髄炎10
46悪性関節リウマチ1
271強直性脊椎炎1
298遺伝性膵炎2

2. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00812851
(ClinicalTrials.gov)
April 200521/11/2008Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)Cramps;Amyotrophic Lateral SclerosisDrug: DronabinolCantonal Hospital of St. GallenALS AssociationCompleted18 YearsN/ABoth24N/ASwitzerland

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000001-23-CZ
(EUCTR)
13/01/202016/08/2018Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosisA phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS Symptomatic relief of spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dronabinol 25 mg/ml, oral drops
Product Code: BX-1
INN or Proposed INN: Dronabinol
Other descriptive name: Dronabinol
Bionorica SENULLNot RecruitingFemale: yes
Male: yes
548Phase 3Hungary;Czech Republic;Spain
2EUCTR2018-002315-98-DK
(EUCTR)
06/12/201809/07/2018The effect of cannabis products on nerve pain and muscle stiffness in patients with multiple sclerosis and in patients with spinal cord injury.The effect of medical cannabis on neuropathic pain and spasticity in patients with Multiple Sclerosis and in patients with spinal cord injury. A multicenter national placebo-controlled trial - The effect of medical cannabis on neuropathic pain and spasticity in patients with MS and SCI Central neuropathic pain and spasticity
MedDRA version: 20.0;Level: PT;Classification code 10028335;Term: Muscle spasticity;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10077975;Term: Central neuropathic pain;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cannabidiol capsule 5 mg
Product Code: N/A
INN or Proposed INN: Cannabidiol
Other descriptive name: CBD
Product Name: Dronabinol capsule 2,5 mg
Product Code: N/A
INN or Proposed INN: DRONABINOL
Other descriptive name: THC
Product Name: Cannabidiol / Dronabinol capsule 5 mg+2,5 mg
Product Code: N/A
INN or Proposed INN: DRONABINOL
Other descriptive name: THC
INN or Proposed INN: Cannabidiol
Other descriptive name: CBD
Aarhus UniversitetshospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
448Phase 2Denmark
3EUCTR2018-000001-23-ES
(EUCTR)
06/11/201823/08/2018Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosisA phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS Symptomatic relief of spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dronabinol
Product Code: BX-1
INN or Proposed INN: Dronabinol
Other descriptive name: Dronabinol
Bionorica SENULLNot RecruitingFemale: yes
Male: yes
548Phase 3Czech Republic;Hungary;Spain
4EUCTR2018-000001-23-HU
(EUCTR)
25/10/201816/08/2018Clinical study to investigate the efficacy and safety of the test substance BX-1 (dronabinol) for the symptomatic relief of spasticity in patients with multiple sclerosisA phase III, multi-centre, randomised, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy and safety of BX-1 for the symptomatic relief of spasticity in patients with multiple sclerosis - BX-1 in spasticity due to MS Symptomatic relief of spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dronabinol 25 mg/ml, oral drops
Product Code: BX-1
INN or Proposed INN: Dronabinol
Other descriptive name: Dronabinol
Bionorica SENULLNot RecruitingFemale: yes
Male: yes
548Phase 3Czech Republic;Hungary;Spain
5EUCTR2010-022033-28-NL
(EUCTR)
10/01/201126/10/2010A study investigating safety, tolerability and efficacy of ECP002A (?9-THC) in Multiple Sclerosis patients suffering from spasticity and pain.A two-phased, randomized, double blind, placebo-controlled study of ECP002A (?9-THC) to determine safety, tolerability and efficacy in Multiple Sclerosis patients suffering from spasticity and pain. - ECP002A (?9-THC) in MS patients Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Namisol
Product Code: ECP002A
INN or Proposed INN: dronabinol
Other descriptive name: Namisol
Echo Pharmaceuticals B.V.NULLNot RecruitingFemale: yes
Male: yes
Netherlands
6NCT00959218
(ClinicalTrials.gov)
June 200713/8/2009Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple SclerosisMulti-centre, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Patients With Multiple Sclerosis Associated With Central Neuropathic PainCentral Neuropathic Pain in Multiple SclerosisDrug: Dronabinol;Drug: PlaceboBionorica Research GmbHNULLCompleted18 Years70 YearsBoth240Phase 3Germany
7EUCTR2006-004255-38-DE
(EUCTR)
17/01/200720/02/2007Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic painMulti-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain Patients with multiple sclerosis associated with central neuropathic pain
MedDRA version: 8.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain
Product Name: dronabinol
Product Code: cnp-MS-0601
INN or Proposed INN: dronabinol
Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol
Bionorica research GmbHNULLNot RecruitingFemale: yes
Male: yes
240Austria;Germany
8EUCTR2006-004255-38-DK
(EUCTR)
15/01/200718/12/2006Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central painMulti-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central pain Patients with multiple sclerosis associated with central neuropathic pain
MedDRA version: 8.1;Level: LLT;Classification code 10054095;Term: Neuropathic pain
Product Name: dronabinol
Product Code: cnp-MS-0601
INN or Proposed INN: dronabinol
Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol
Bionorica research GmbHNULLNot RecruitingFemale: yes
Male: yes
240Phase 3Austria;Denmark;Germany
9EUCTR2006-004255-38-AT
(EUCTR)
05/01/200706/11/2006Multi-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic painMulti-centre, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of the pain relieving effect of Dronabinol in patients with multiple sclerosis associated with central neuropathic pain Patients with multiple sclerosis associated with central neuropathic pain
MedDRA version: 16.0;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852
Product Name: dronabinol
Product Code: cnp-MS-0601
INN or Proposed INN: dronabinol
Other descriptive name: (-)-trans-delta-9-Tetrahydrocannabinol
Bionorica research GmbHNULLNot RecruitingFemale: yes
Male: yes
240Austria;Germany
10EUCTR2005-002728-33-GB
(EUCTR)
28/02/200629/12/2005Cannabinoid Use in Progressive Inflammatory brain Disease - CUPIDCannabinoid Use in Progressive Inflammatory brain Disease - CUPID Progressive multiple sclerosisProduct Name: Dronabinol
INN or Proposed INN: Dronabinol
Plymouth Hospitals NHS TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
492United Kingdom

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004226-15-DK
(EUCTR)
26/10/201805/01/2018 Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied. CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Cannabidiol tablet 10 mg
Other descriptive name: CANNABIDIOL
Product Name: Dronabinol capsule 2.5. mg
INN or Proposed INN: DRONABINOL
King Christian 10th Hospital for RheumatologyNULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noDenmark

271. 強直性脊椎炎


臨床試験数 : 574 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004226-15-DK
(EUCTR)
26/10/201805/01/2018 Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied. CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Cannabidiol tablet 10 mg
Other descriptive name: CANNABIDIOL
Product Name: Dronabinol capsule 2.5. mg
INN or Proposed INN: DRONABINOL
King Christian 10th Hospital for RheumatologyNULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noDenmark

298. 遺伝性膵炎


臨床試験数 : 95 薬物数 : 148 - (DrugBank : 51) / 標的遺伝子数 : 53 - 標的パスウェイ数 : 142
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-000730-19-NL
(EUCTR)
23/08/201212/03/2012?9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal PainThe analgesic efficacy of ?9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain: a Randomized, Double-blinded, Placebo-controlled, Parallel Design - Delta-Pain II Chronic pancreatitis with persistant abdominal pain
MedDRA version: 14.1;Level: PT;Classification code 10033649;Term: Pancreatitis chronic;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Namisol
Product Code: A04AD10
INN or Proposed INN: DRONABINOL
Other descriptive name: Tetrahydro-6,6,9-tri methyl-3-penthyl-6 H-dibenzo[ b,d ]pyran-1-ol
Radboud University Nijmegen Medical CentreNULLNot RecruitingFemale: yes
Male: yes
68Phase 2Netherlands
2EUCTR2011-000647-24-NL
(EUCTR)
26/07/201112/05/2011Efficacy study of ?9-THC to treat persistent abdominal pain as a result of chronic pancreas inflammationThe safety, tolerability, and analgesic efficacy of ?9-THC (Namisol®) in chronic pancreatitis patients suffering from persistent abdominal pain - ?9-THC in chronic pain patients with abdominal pain as a result of chronic pancreatitis
MedDRA version: 13.1;Level: PT;Classification code 10033649;Term: Pancreatitis chronic;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Namisol
Product Code: A04AD10
INN or Proposed INN: DRONABINOL
Radboud University Nijmegen Medical CentreNULLNot RecruitingFemale: no
Male: yes
Netherlands