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	3

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	NCT03716388 (ClinicalTrials.gov)	December 1, 2018	21/10/2018	Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC	Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC : a Pilot Study	Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate	Biological: Fecal Microbiota Transplantation;Drug: Mesalamine Granules;Other: Placebo infusion;Other: Placebo granules	Dayanand Medical College and Hospital	Colitis & Crohn's Foundation (India)	Recruiting	18 Years	75 Years	All	20	Phase 3	India
2	NCT00326209 (ClinicalTrials.gov)	December 22, 2005	12/5/2006	Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission	A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation	Ulcerative Colitis	Drug: Encapsulated Mesalamine Granules (eMG)	Bausch Health Americas, Inc.	NULL	Completed	18 Years	N/A	All	393	Phase 3	United States
3	NCT00746447 (ClinicalTrials.gov)	May 2005	3/9/2008	Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)	Double-blind, Double-dummy, Randomised, Multicentre, 12-months, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules vs. Once Daily 1.5 g Mesalazine Granules vs. Three Times Daily 0.5 g Mesalazine Granules for Maintenance of Remission in Patients With Ulcerative Colitis	Colitis, Ulcerative;Recurrence	Drug: mesalamine granules	Dr. Falk Pharma GmbH	NULL	Completed	18 Years	75 Years	Both	648	Phase 3	Germany

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

NCT03716388
(ClinicalTrials.gov)

December 1, 2018

21/10/2018

Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC

Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC : a Pilot Study

Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate

Biological: Fecal Microbiota Transplantation;Drug: Mesalamine Granules;Other: Placebo infusion;Other: Placebo granules

Dayanand Medical College and Hospital

Colitis & Crohn's Foundation (India)

Recruiting

18 Years

75 Years

All

Phase 3

India

NCT00326209
(ClinicalTrials.gov)

December 22, 2005

12/5/2006

Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission

A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation

Ulcerative Colitis

Drug: Encapsulated Mesalamine Granules (eMG)

Bausch Health Americas, Inc.

NULL

Completed

18 Years

N/A

All

393

Phase 3

United States

NCT00746447
(ClinicalTrials.gov)

May 2005

3/9/2008

Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)

Double-blind, Double-dummy, Randomised, Multicentre, 12-months, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules vs. Once Daily 1.5 g Mesalazine Granules vs. Three Times Daily 0.5 g Mesalazine Granules for Maintenance of Remission in Patients With Ulcerative Colitis

Colitis, Ulcerative;Recurrence

Drug: mesalamine granules

Dr. Falk Pharma GmbH

NULL

Completed

18 Years

75 Years

Both

648

Phase 3

Germany