Ursodeoxycholic Acid Capsules ( DrugBank: Ursodeoxycholic acid )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
93原発性胆汁性胆管炎17

93. 原発性胆汁性胆管炎


臨床試験数 : 298 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
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PhaseCountries
1ChiCTR2000037243
2021-01-012020-08-27Clinical Study of therapeutic effect of Yuyinyanggan decoction on patients of primary biliary cholangitis with 25-OH-D by LC-MS/MSClinical Study of therapeutic effect of Yuyinyanggan decoction on patients of primary biliary cholangitis with 25-OH-D by LC-MS/MS primary biliary cholangitisexperimental group:Yuyinyanggan decoction+Ursodeoxycholic Acid Capsules;control group:placebo of Yuyinyanggan decoction +Ursodeoxycholic Acid Capsules ;Shanghai Municipal Hospital of Traditional Chinese MedicineNULLPendingBothexperimental group:96;control group:96;China
2ITMCTR2000004008
2021-01-012020-08-27Clinical Study of therapeutic effect of Yuyinyanggan decoction on patients of primary biliary cholangitis with 25-OH-D by LC-MS/MSClinical Study of therapeutic effect of Yuyinyanggan decoction on patients of primary biliary cholangitis with 25-OH-D by LC-MS/MS primary biliary cholangitiscontrol group:placebo of Yuyinyanggan decoction +Ursodeoxycholic Acid Capsules ;experimental group:Yuyinyanggan decoction+Ursodeoxycholic Acid Capsules;Shanghai Municipal Hospital of Traditional Chinese MedicineNULLPendingBothcontrol group:96;experimental group:96;China
3EUCTR2007-004040-70-PL
(EUCTR)
30/04/201320/03/2013Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 17.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;Sweden
4NCT01857284
(ClinicalTrials.gov)
September 200916/5/2013Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary CirrhosisA Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical Trial to Investigate Safety and Efficacy of Tauroursodeoxycholic Acid Capsules in Treatment of Adult Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: Tauroursodeoxycholic Acid Capsules;Drug: Ursodeoxycholic Acid CapsulesBeijing Friendship HospitalBeijing Trendful Kangjian Medical Information Consulting Limited CompanyCompleted18 Years70 YearsBoth216Phase 3China
5EUCTR2007-004040-70-GB
(EUCTR)
01/06/200919/08/2008Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBCDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Patients with Primary Biliary Cirrhosis at risk of disease progression
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
183Phase 3Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
6EUCTR2007-004040-70-IT
(EUCTR)
20/05/200922/05/2009Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Patients with PBC and with risk of a progression of this disease.
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budesonide
INN or Proposed INN: Budesonide
Trade Name: acido ursodessicolico
INN or Proposed INN: Ursodeoxycholic acid
DR. FALK PHARMA GMBHNULLNot RecruitingFemale: yes
Male: yes
183Phase 3Sweden;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Poland;Denmark;Germany;Netherlands
7EUCTR2007-004040-70-AT
(EUCTR)
19/03/200923/06/2008Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBCDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Patients with Primary Biliary Cirrhosis at risk of disease progression
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
183Phase 3Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
8NCT00746486
(ClinicalTrials.gov)
February 20093/9/2008Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC)Double-blind, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study Comparing the Combination of Ursodeoxycholic Acid Capsules Plus Budesonide Capsules to Ursodeoxycholic Acid Capsules Plus Placebo in the Treatment of Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: budesonide;Drug: budesonide placeboDr. Falk Pharma GmbHNULLTerminated18 YearsN/AAll62Phase 3France;Germany
9EUCTR2007-004040-70-DK
(EUCTR)
29/01/200919/11/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 16.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
10EUCTR2007-004040-70-LT
(EUCTR)
22/12/200816/09/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
11EUCTR2007-004040-70-FI
(EUCTR)
10/11/200825/06/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 17.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
12EUCTR2007-004040-70-HU
(EUCTR)
18/10/200804/08/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 14.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
13EUCTR2007-004040-70-ES
(EUCTR)
01/10/200801/08/2008Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de fase III, de grupos paralelos, para comparar la combinación de capsulas de ácido ursodeoxicólico y capsulas de budesonida con la combinación de capsulas de ácido ursodeoxicólico y capsulas placebo en el tratamiento de la cirrosis biliar primaria(Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis) - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBCEstudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de fase III, de grupos paralelos, para comparar la combinación de capsulas de ácido ursodeoxicólico y capsulas de budesonida con la combinación de capsulas de ácido ursodeoxicólico y capsulas placebo en el tratamiento de la cirrosis biliar primaria(Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis) - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Pacientes con cirrosis biliar primaria con riesgo de progresíon de la enfermedadPatients with Primary Biliary Cirrhosis at risk of disease progression
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
183Phase 3Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
14EUCTR2007-004040-70-SE
(EUCTR)
22/09/200802/06/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 17.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
15EUCTR2007-004040-70-FR
(EUCTR)
09/09/200809/06/2008Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBCDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Patients with Primary Biliary Cirrhosis at risk of disease progression
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 3Hungary;Finland;United Kingdom;Germany;Netherlands;Denmark;France;Spain;Italy;Austria;Lithuania;Sweden
16EUCTR2007-004040-70-NL
(EUCTR)
11/08/200823/06/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;Sweden
17EUCTR2007-004040-70-DE
(EUCTR)
15/05/200814/03/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden