DDrare: Database of Drug Development for Rare Diseases

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	1

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03412682 (ClinicalTrials.gov)	March 2, 2018	22/1/2018	To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis	A Phase 3, Multi-centre, Randomised, Double-blind, Active-controlled, Parallel-group Trial Investigating the Efficacy and Safety of FE 999315 Following 8 Weeks of Treatment for Mild to Moderate Active Ulcerative Colitis in Japanese Subjects	Colitis, Ulcerative	Drug: Budesonide (6 mg);Drug: Budesonide (9 mg);Drug: Mesalazine (3,600 mg)	Ferring Pharmaceuticals	NULL	Completed	16 Years	75 Years	All	274	Phase 3	Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03412682
(ClinicalTrials.gov)

March 2, 2018

22/1/2018

To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis

A Phase 3, Multi-centre, Randomised, Double-blind, Active-controlled, Parallel-group Trial Investigating the Efficacy and Safety of FE 999315 Following 8 Weeks of Treatment for Mild to Moderate Active Ulcerative Colitis in Japanese Subjects

Colitis, Ulcerative

Drug: Budesonide (6 mg);Drug: Budesonide (9 mg);Drug: Mesalazine (3,600 mg)

Ferring Pharmaceuticals

NULL

Completed

16 Years

75 Years

All

274

Phase 3

Japan