Dersalazine sodium ( DrugBank: Dersalazine )


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5

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2008-004610-27-SK
(EUCTR)
06/04/200909/02/2009A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitisA double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis Mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Dersalazine sodium
Product Code: UR-12746-S
INN or Proposed INN: dersalazine sodium
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: Mesalazine
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: mesalazine
Palau Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Slovakia;Spain;Belgium
2EUCTR2008-004610-27-HU
(EUCTR)
26/02/200915/12/2008A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitisA double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis Mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Dersalazine sodium
Product Code: UR-12746-S
INN or Proposed INN: dersalazine sodium
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: Mesalazine
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: mesalazine
Palau Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Belgium;Spain
3EUCTR2008-004610-27-BE
(EUCTR)
02/12/200824/07/2008A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitisA double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis Mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Dersalazine sodium
Product Code: UR-12746-S
INN or Proposed INN: dersalazine sodium
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: Mesalazine
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: mesalazine
Palau Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2Hungary;Belgium;Spain
4NCT00808977
(ClinicalTrials.gov)
December 200815/12/2008A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative ColitisA Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active ColitisUlcerative ColitisDrug: Dersalazine sodium;Drug: Mesalazine;Drug: PlaceboPalau Pharma S.A.NULLCompleted18 Years65 YearsBoth80Phase 2Belgium;Hungary;Slovakia;Spain
5EUCTR2008-004610-27-ES
(EUCTR)
25/11/200826/09/2008Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitisEstudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis Colitis ulcerosa de leve a moderadaMild to moderate ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Dersalazina sodica
INN or Proposed INN: dersalazine sodium
Trade Name: LIXACOL
Product Name: LIXACOL
INN or Proposed INN: MESALAZINA
Other descriptive name: MESALAZINE
Trade Name: LIXACOL
Product Name: LIXACOL
INN or Proposed INN: MESALAZINA
Other descriptive name: MESALAZINE
Palau Pharma S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2Hungary;Belgium;Spain