SPD476 (mesalazine) ( DrugBank: Mesalazine )


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16

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
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size
PhaseCountries
1EUCTR2004-004184-29-DK
(EUCTR)
10/09/200910/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
830Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
2EUCTR2004-004184-29-NL
(EUCTR)
15/01/200817/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
826Phase 3Portugal;Czech Republic;Hungary;Spain;Denmark;Germany;Netherlands;United Kingdom;Sweden
3EUCTR2004-004184-29-PT
(EUCTR)
14/12/200711/10/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
826Phase 3Hungary;Portugal;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
4EUCTR2004-004184-29-SE
(EUCTR)
22/11/200727/09/2007A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
830Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
5EUCTR2004-000734-36-CZ
(EUCTR)
13/07/200508/10/2004A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission.A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission. Subject not in remission of Ulcerative Colitis (UC-DAI score of >1) at the End of Study/Early Withdrawal Visit of Study 301 or 302.Subject in remission of UC (UC-DAI<1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1 point reduction in the sigmoidocsopy score from Study 301 or 302 baseline) at the End of Study Visit of Study 301 or 302, or at the end of the Acute Phase of this studyProduct Name: Mesalazine
Product Code: SPD476
INN or Proposed INN: Mesalazinum
Other descriptive name: 5-amino salicylic acid (5-ASA)
Shire Pharmaceutical Development Inc.NULLNot RecruitingFemale: yes
Male: yes
125Phase 3Czech Republic
6EUCTR2004-004184-29-DE
(EUCTR)
06/06/200501/03/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitisProduct Name: None given
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
410Phase 3Portugal;Hungary;Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Spain;Sweden
7EUCTR2004-004184-29-GB
(EUCTR)
31/05/200523/02/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Name: Mezavant XL 1200 mg gastro-resistant prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot Recruiting Female: yes
Male: yes
826 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden
8EUCTR2004-004184-29-ES
(EUCTR)
05/05/200503/04/2006A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis.A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. Ulcerative colitis
MedDRA version: 3.2;Level: LLT;Classification code 10045365
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
410Phase 3Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden
9EUCTR2004-004184-29-CZ
(EUCTR)
13/04/200511/04/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets.
Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
826Phase 3Portugal;Hungary;Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Spain;Sweden
10NCT00151892
(ClinicalTrials.gov)
April 8, 20057/9/2005Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative ColitisA Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative ColitisUlcerative ColitisDrug: SPD476;Drug: AsacolShireNULLCompleted18 YearsN/AAll829Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Chile;Czechia;Denmark;France;Germany;Hungary;India;Korea, Republic of;Mexico;Netherlands;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Singapore;South Africa;Spain;Sweden;Taiwan;United Kingdom;Czech Republic
11EUCTR2004-004184-29-HU
(EUCTR)
30/03/200510/02/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets.
Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
826Phase 3Portugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden
12EUCTR2004-000733-12-CZ
(EUCTR)
14/07/200401/07/2004A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis.A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis. Subjects who have newly diagnosed or have a diagnosis of relapsing (relapses1 and a Physician Global Assessment of <2). The original diagnosis of UC must be established by sigmoidoscopy, colonoscopy, or barium enema and have compatible histology.Product Name: Mesalazine
Product Code: SPD476
INN or Proposed INN: Mesalazinum
Other descriptive name: 5-amino salicylic acid (5-ASA)
Shire Pharmaceutical Development IncNULLNot RecruitingFemale: yes
Male: yes
255Phase 3Czech Republic
13NCT00548574
(ClinicalTrials.gov)
December 4, 200323/10/2007Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative ColitisA Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine;Drug: MesalazineShireNULLCompleted18 YearsN/AAll343Phase 3Belgium
14NCT00151944
(ClinicalTrials.gov)
November 26, 20037/9/2005Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.Colitis, UlcerativeDrug: SPD476 (mesalazine)ShireNULLCompleted18 YearsN/AAll400Phase 3NULL
15NCT00503243
(ClinicalTrials.gov)
September 30, 200316/7/2007Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative ColitisA Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative ColitisColitis, UlcerativeDrug: Delayed and extended release mesalazineShireNULLCompleted18 YearsN/AAll280Phase 3United States
16NCT00545389
(ClinicalTrials.gov)
February 10, 200316/10/2007Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476A Phase II, Randomized, Multi-centre, Double-blind, Parallel-group, Dose-ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once DailyColitis, UlcerativeDrug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazineShireNULLCompleted18 YearsN/AAll38Phase 2Belgium