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
96	クローン病	2

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	EUCTR2004-004083-77-SK (EUCTR)	29/06/2005	31/01/2005	A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease	A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease	Moderate active Crohn disease	Trade Name: Mesalazine EC 500 mg Product Name: Mesalazine EC 500 mg INN or Proposed INN: mesalazine Trade Name: Salofalk 500 mg Product Name: Salofalk 500 mg INN or Proposed INN: mesalazine	Disphar International B.V.	NULL	Not Recruiting			Female: yes Male: yes	436	Phase 3	Czech Republic;Slovakia
2	EUCTR2004-004083-77-CZ (EUCTR)	13/12/2004	02/12/2004	A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease	A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease	Moderate active Crohn disease	Product Name: Mesalazine EC 500 mg INN or Proposed INN: mesalazine Product Name: Salofalk 500 mg INN or Proposed INN: mesalazine	Disphar International B.V.	NULL	Not Recruiting			Female: yes Male: yes	436		Czech Republic

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

EUCTR2004-004083-77-SK
(EUCTR)

29/06/2005

31/01/2005

A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease

Moderate active Crohn disease

Trade Name: Mesalazine EC 500 mg
Product Name: Mesalazine EC 500 mg
INN or Proposed INN: mesalazine
Trade Name: Salofalk 500 mg
Product Name: Salofalk 500 mg
INN or Proposed INN: mesalazine

Disphar International B.V.

NULL

Not Recruiting

Female: yes
Male: yes

436

Phase 3

Czech Republic;Slovakia

EUCTR2004-004083-77-CZ
(EUCTR)

13/12/2004

02/12/2004

Moderate active Crohn disease

Product Name: Mesalazine EC 500 mg
INN or Proposed INN: mesalazine
Product Name: Salofalk 500 mg
INN or Proposed INN: mesalazine

Disphar International B.V.

NULL

Not Recruiting

Female: yes
Male: yes

436

Czech Republic