GLPG0974 ( DrugBank: GLPG-0974 )


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4

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
1EUCTR2012-005521-73-CZ
(EUCTR)
16/05/201301/03/2013Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitisExploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis - Proof-of-concept oral dose, safety, tolerability, efficacy, PK and PD study Mild to moderate Ulcerative Colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GLPG0974
INN or Proposed INN: GLPG0974
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Czech Republic;Belgium;Latvia
2EUCTR2012-005521-73-LV
(EUCTR)
29/04/201313/03/2013Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitisExploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis - Proof-of-concept oral dose, safety, tolerability, efficacy, PK and PD study Mild to moderate Ulcerative Colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GLPG0974
INN or Proposed INN: GLPG0974
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Czech Republic;Latvia
3NCT01829321
(ClinicalTrials.gov)
April 20139/4/2013Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative ColitisExploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of GLPG0974 in Subjects With Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: GLPG0974;Drug: PlaceboGalapagos NVNULLCompleted18 Years75 YearsBoth45Phase 2Belgium;Czech Republic;Latvia;Slovakia
4EUCTR2012-005521-73-BE
(EUCTR)
20/03/201308/02/2013Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitisExploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis - Proof-of-concept oral dose, safety, tolerability, efficacy, PK and PD study Mild to moderate Ulcerative Colitis
MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: GLPG0974
INN or Proposed INN: GLPG0974
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Czech Republic;Belgium;Latvia