ST 261 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎14

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-004765-32-NL
(EUCTR)
27/08/201225/04/2012Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylatesPhase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST 261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative Colitis Mild ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PROPIONYL L-CARNITINE HYDROCHLORIDE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.NULLNot RecruitingFemale: yes
Male: yes
444Phase 3Czech Republic;Slovakia;Belgium;Russian Federation;Israel;Netherlands;Italy
2EUCTR2011-004770-28-AT
(EUCTR)
26/06/201215/02/2012Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylatesPhase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis Mild ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.NULLNot RecruitingFemale: yes
Male: yes
444Phase 3Hungary;Poland;Spain;Lithuania;Austria;Germany;Latvia
3EUCTR2011-004770-28-DE
(EUCTR)
03/05/201209/02/2012Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylatesPhase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis Mild ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Propionylcarnitinhydrochlorid
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.NULLNot RecruitingFemale: yes
Male: yes
444Phase 3Hungary;Poland;Spain;Lithuania;Austria;Latvia;Germany
4EUCTR2011-004765-32-IT
(EUCTR)
26/04/201223/07/2012Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylatesPhase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis Mild ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
SIGMA-TAUNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Czech Republic;Belgium;Netherlands;Italy
5EUCTR2011-004770-28-LT
(EUCTR)
12/04/201215/02/2012Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylatesPhase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-Carnitine in Ulcerative Colitis Mild ulcerative colitis
MedDRA version: 16.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.NULLNot RecruitingFemale: yes
Male: yes
444Phase 3France;Hungary;Spain;Poland;Lithuania;Austria;Latvia;Germany
6EUCTR2011-004770-28-HU
(EUCTR)
21/03/201223/01/2012Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylatesPhase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis Mild ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.NULLNot RecruitingFemale: yes
Male: yes
444Phase 3Hungary;Poland;Spain;Lithuania;Austria;Germany;Latvia
7EUCTR2011-004770-28-PL
(EUCTR)
17/03/201216/02/2012Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylatesPhase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-Carnitine in Ulcerative Colitis Mild ulcerative colitis
MedDRA version: 15.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.NULLNot RecruitingFemale: yes
Male: yes
444Phase 3France;Hungary;Spain;Poland;Lithuania;Austria;Latvia;Germany
8EUCTR2011-004770-28-LV
(EUCTR)
29/02/201224/01/2012Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylatesPhase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-Carnitine in Ulcerative Colitis Mild ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.NULLNot RecruitingFemale: yes
Male: yes
444Phase 3France;Hungary;Spain;Poland;Lithuania;Austria;Germany;Latvia
9EUCTR2011-004770-28-ES
(EUCTR)
28/02/201211/01/2012Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylatesPhase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis Mild ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.NULLNot RecruitingFemale: yes
Male: yes
444Phase 3France;Hungary;Poland;Spain;Lithuania;Austria;Latvia;Germany
10EUCTR2011-004765-32-CZ
(EUCTR)
21/02/201215/12/2011Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylatesPhase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis Mild ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.NULLNot RecruitingFemale: yes
Male: yes
444Phase 3Czech Republic;Belgium;Netherlands;Italy
11EUCTR2011-004765-32-SK
(EUCTR)
19/01/201209/12/2011Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylatesPhase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis Mild ulcerative colitis
MedDRA version: 14.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.NULLNot RecruitingFemale: yes
Male: yes
444Phase 3Czech Republic;Slovakia;Belgium;Netherlands;Italy
12EUCTR2011-004765-32-BE
(EUCTR)
10/01/201206/12/2011Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylatesPhase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative Colitis Mild ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.NULLNot RecruitingFemale: yes
Male: yes
444Phase 3Czech Republic;Slovakia;Belgium;Netherlands;Italy
13EUCTR2005-003471-20-LT
(EUCTR)
26/06/200812/02/2008Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine ST 261 Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable TreatmentPhase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine ST 261 Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment Ulcerative Colitis
MedDRA version: 9.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative
Product Name: Propionyl-L-carnitine
Product Code: ST261
INN or Proposed INN: Propionyl-L-Carnitine
SIGMA-TAUNULLNot RecruitingFemale: yes
Male: yes
120Phase 2Italy;Lithuania
14EUCTR2005-003471-20-IT
(EUCTR)
07/12/200517/01/2007Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable TreatmentPhase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment ULCERATIVE COLITIS
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Propionyl-L-carnitine
Product Code: ST261
INN or Proposed INN: Levocarnitine
SIGMA-TAUNULLNot RecruitingFemale: yes
Male: yes
Phase 2Lithuania;Italy