COLAL PRED ( 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7

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
1EUCTR2004-005032-35-BE
(EUCTR)
06/03/200723/11/2006A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. Moderate acute ulcerative colitis.Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Alizyme Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
890Hungary;Czech Republic;United Kingdom;Denmark;Belgium;Spain;Italy;Sweden
2EUCTR2004-005032-35-IT
(EUCTR)
10/05/200619/01/2007A Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative ColitisA Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative Colitis Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: COLAL PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone
Product Name: COLAL PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone
Product Name: COLAL PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone
Trade Name: PREDNISOLONE
INN or Proposed INN: Prednisolone
ALIZYMENULLNot RecruitingFemale: yes
Male: yes
890Phase 3Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
3EUCTR2004-005032-35-SE
(EUCTR)
17/11/200514/09/2005A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. Moderate acute ulcerative colitis.Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Alizyme Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
890Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
4EUCTR2004-005032-35-CZ
(EUCTR)
04/11/200516/09/2005A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. Moderate acute ulcerative colitis.Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Alizyme Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
890Hungary;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Italy;Sweden
5EUCTR2004-005032-35-DK
(EUCTR)
24/10/200504/10/2005A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. Moderate acute ulcerative colitis.Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Alizyme Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
890Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
6EUCTR2004-005032-35-HU
(EUCTR)
24/10/200522/09/2005A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. Moderate acute ulcerative colitis.Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Trade Name: Prednisolone
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Alizyme Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
890Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
7EUCTR2004-005032-35-GB
(EUCTR)
11/10/200524/02/2005A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. Moderate acute ulcerative colitis.Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Trade Name: Prednisolone Tablets B.P. 5mg
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Alizyme Therapeutics LimitedNULLNot Recruiting Female: yes
Male: yes
890 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noHungary;Czech Republic;Belgium;Spain;Denmark;Italy;United Kingdom;Sweden