Asacol (mesalamine) Delayed-release Tablets ( DrugBank: Mesalamine )


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2

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
1EUCTR2004-000611-25-IE
(EUCTR)
19/10/200416/08/2004A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - COREA Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE Maintenance of remission of ulcerative colitisProduct Name: OPC-6535
Product Code: OPC-6535
Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid
Trade Name: Asacol (mesalamine) Delayed-release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalamine
Other descriptive name: 5-amino-2-hydroxybenzoic acid
Otsuka Maryland Research Institute, Inc.NULLNot RecruitingFemale: yes
Male: yes
1725Phase 3Hungary;Ireland
2EUCTR2004-000611-25-HU
(EUCTR)
15/10/200421/07/2004A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - COREA Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE Maintenance of remission of ulcerative colitisProduct Name: OPC-6535
Product Code: OPC-6535
Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid
Trade Name: Asacol (mesalamine) Delayed-release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalamine
Other descriptive name: 5-amino-2-hydroxybenzoic acid
Otsuka Maryland Research Institute, Inc.NULLNot RecruitingFemale: yes
Male: yes
1725Phase 3Hungary;Ireland