Opc-6535    (DrugBank: -)

2 diseases
IDDisease name (Link within this page)Number of trials
96Crohn disease2
97Ulcerative colitis8

96. Crohn disease    [ 2,209 clinical trials,   1,276 drugs,   (DrugBank: 240 drugs),   166 drug target genes,   210 drug target pathways]
Searched query = "Crohn disease", "Terminal ileitis"
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.
2 / 2,209 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
Inclusion_
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PhaseCountries
1NCT00989573
(ClinicalTrials.gov)
October 20092/10/2009A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's DiseaseA Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's DiseaseCrohn's DiseaseDrug: Placebo;Drug: OPC-6535Otsuka Pharmaceutical Co., Ltd.NULLCompleted18 Years64 YearsBoth191Phase 2;Phase 3Japan;Korea, Republic of
2NCT00317369
(ClinicalTrials.gov)
May 200621/4/2006A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's DiseaseA Dose-Finding Study of OPC-6535 in Patients With Active Crohn's DiseaseCrohn DiseaseDrug: OPC-6535(Tetomilast)Otsuka Pharmaceutical Co., Ltd.NULLTerminated16 Years65 YearsBoth60Phase 2Japan

97. Ulcerative colitis    [ 2,269 clinical trials,   1,331 drugs,   (DrugBank: 241 drugs),   114 drug target genes,   181 drug target pathways]
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.
8 / 2,269 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00317356
(ClinicalTrials.gov)
May 200621/4/2006A Dose-Finding Study of OPC-6535 in Patients With Active Ulcerative ColitisA Dose-Finding Study of OPC-6535 in Patients With Active Ulcerative ColitisColitis, UlcerativeDrug: OPC-6535(Tetomilast)Otsuka Pharmaceutical Co., Ltd.NULLTerminated18 Years65 YearsBoth160Phase 2Japan
2EUCTR2005-003724-19-CZ
(EUCTR)
21/11/200505/10/2005A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 ProtocolA Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol Active Ulcerative Colitis
MedDRA version: 8.0;Level: LLT;Classification code 10058816
Product Name: OPC-6535
Product Code: OPC-6535
INN or Proposed INN: Not applicable
Other descriptive name: OPC-6535
Otsuka Maryland Research Institute, Inc.NULLNot RecruitingFemale: yes
Male: yes
375Phase 3Hungary;Czech Republic
3EUCTR2005-003724-19-HU
(EUCTR)
24/10/200507/09/2005A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 ProtocolA Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol Active Ulcerative Colitis
MedDRA version: 8.0;Level: LLT;Classification code 10058816
Product Name: OPC-6535
Product Code: OPC-6535
INN or Proposed INN: Not applicable
Other descriptive name: OPC-6535
Otsuka Maryland Research Institute, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
375Phase 3Hungary
4EUCTR2004-000611-25-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
5EUCTR2004-000611-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT00092508
(ClinicalTrials.gov)
May 200422/9/2004CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) RemissionPhase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis RemissionUlcerative ColitisDrug: OPC-6535;Drug: Asacol®Otsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years80 YearsBoth1725Phase 3United States
7NCT00064441
(ClinicalTrials.gov)
May 20038/7/2003FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative ColitisFACTS I: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: OPC-6535 Tablets (drug)Otsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years80 YearsBoth375Phase 3United States
8NCT00064454
(ClinicalTrials.gov)
May 20038/7/2003FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative ColitisFACTS II: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: OPC-6535 Tablets (drug)Otsuka Pharmaceutical Development & Commercialization, Inc.NULLCompleted18 Years80 YearsBoth375Phase 3United States