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	NCT00603733 (ClinicalTrials.gov)	October 2007	16/1/2008	Canadian Active & Maintenance Modified Pentasa Study	A Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa® (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa® (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 Weeks	Active Ulcerative Colitis;Remission of Ulcerative Colitis	Drug: 5-ASA (5-Aminosalicylate)	Ferring Pharmaceuticals	NULL	Completed	18 Years	75 Years	All	288	Phase 3	Canada

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

NCT00603733
(ClinicalTrials.gov)

October 2007

16/1/2008

Canadian Active & Maintenance Modified Pentasa Study

A Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa® (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa® (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 Weeks

Active Ulcerative Colitis;Remission of Ulcerative Colitis

Drug: 5-ASA (5-Aminosalicylate)

Ferring Pharmaceuticals

NULL

Completed

18 Years

75 Years

All

288

Phase 3

Canada