A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease

PHASE2TerminatedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2013

Conditions
Crohn's Disease
Interventions
DRUG

TU-100

15g daily, orally as 5g three times daily for 8 consecutive weeks

DRUG

Matching Placebo

15g as 5g three times daily, orally for 8 consecutive weeks

Trial Locations (27)

11021

Long Island Clinical Research Associates, LLP, Great Neck

11423

NY Scientific CORP, Hollis

20815

Metropolitan Gastroenterology Group. PC, Chevy Chase

21204

Endoscopic Microsurgery Associates PA, Towson

22765

Clinical Research of West Florida, Inc, Clearwater

27103

PMG Research of Winston-Salem, LLC, Winston-Salem

28144

PMG Research of Salisbury, Salisbury

31210

Gastroenterology Associates of Central Georgia, Macon

32789

Shafran Gastroenterology Center, Winter Park

34102

Gastroenterology Group of Naples, Naples

39564

Digestive Health Center, Ocean Springs

40202

University of Louisville School of Medicine, Louisville

45014

Ohio Gastroenterology and Liver, Cincinnati

45219

Consultants for Clinical Research, Cincinnati

48047

Clinical Research Institute of Michigan, Chesterfield

48098

Center for Digestive Health, Troy

60637

University of Chicago Hospital Medical Center, Chicago

63128

St. Louis Center for Clinical Research, St Louis

72211

Preferred Research Partners Inc, Little Rock

80215

Rocky Mountain Gastroenterology Associates, Lakewood

84405

Advanced Research Institute, Ogden

92880

TRIMED Clinical Trials, Corona

94070

Digestive Care Associates, LLC, San Carlos

94115

University of California at San Francisco, San Francisco

98195

University of Washington Medical Center, Seattle

30542-5020

Atlanta Gastroenterology Associates, LLC, Atlanta

02169

MedRACS, Quincy

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Tsumura USA

INDUSTRY

NCT01388933 - A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease | Biotech Hunter | Biotech Hunter