97. 潰瘍性大腸炎
[臨床試験数:2,269,薬物数:1,331(DrugBank:241),標的遺伝子数:114,標的パスウェイ数:181

Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
10 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004576-57-PL
(EUCTR)
18/05/201901/08/2019Novel budesonide capsules vs. budesonide tabltes in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
2EUCTR2017-004576-57-DE
(EUCTR)
26/04/201908/01/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
3EUCTR2017-004576-57-CZ
(EUCTR)
27/03/201915/03/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
4EUCTR2017-004576-57-LT
(EUCTR)
15/03/201929/01/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
5EUCTR2017-004576-57-SK
(EUCTR)
12/03/201918/01/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-004576-57-HU
(EUCTR)
11/03/201916/01/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
7EUCTR2014-005635-14-LT
(EUCTR)
21/10/201503/07/2015Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitisOpen-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC Patients with active ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg capsules, hard (BUX-PV)
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Lithuania;Latvia
8EUCTR2014-005635-14-HU
(EUCTR)
29/07/201503/06/2015Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitisOpen-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC Patients with active ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg capsules, hard (BUX-PV)
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Lithuania;Latvia
9EUCTR2014-005635-14-LV
(EUCTR)
10/07/201523/02/2015Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitisOpen-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC Patients with active ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg capsules, hard (BUX-PV)
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Lithuania;Latvia
10EUCTR2014-005635-14-DE
(EUCTR)
08/06/201518/02/2015Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitisOpen-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC Patients with active ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg capsules, hard (BUX-PV)
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Lithuania;Latvia;Germany