|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Tsumura USA |
|---|---|
| Collaborator: |
INC Research |
| Information provided by (Responsible Party): | Tsumura USA |
| ClinicalTrials.gov Identifier: | NCT01388933 |
Purpose
The purpose of this study is to determine whether Daikenchuto(TU-100)is effective in the treatment of Crohn's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Drug: TU-100 Drug: Matching Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease |
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TU-100
15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily)
|
Drug: TU-100
15g daily, orally as 5g three times daily for 8 consecutive weeks
Other Names:
|
|
Placebo Comparator: Matching placebo
Matching placebo given 5g three times daily orally for 8 consecutive weeks
|
Drug: Matching Placebo
15g as 5g three times daily, orally for 8 consecutive weeks
Other Name: Placebo
|
Crohn's disease, a chronic condition resulting in inflammation of the gastrointestinal tract (GI), causes a person to experience persistent symptoms of inflammatory bowel disease, including abdominal pain, nausea, vomiting, rectal bleeding, diarrhea, and constipation, with infrequent bowel movements that are at times accompanied by a sensation of incomplete emptying after having a bowel movement. Tsumura's TU-100 is a modern herbal product that has been approved as a prescription drug in Japan. Several lines of evidence indicate that TU-100 attenuates intestinal inflammation in Crohn's disease by increasing intestinal blood flow and stimulating a protective lining of intestinal mucus which produces an anti-inflammatory effect. TU-100 may attenuate pathological changes in the intestine and reduce symptoms in patients with Crohn's disease.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Digestive Care Associates, LLC | Recruiting |
| San Carlos, California, United States, 94070 | |
| Contact: Prutha Shah 650-596-8800 studysite@sbcglobal.net | |
| Principal Investigator: Scott D Levenson, MD | |
| University of California at San Francisco | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Yelena Idomsky 415-502-4444 Yelena.Idomsky@ucsfmedctr.org | |
| Principal Investigator: Uma Mahadevan, MD | |
| United States, Colorado | |
| Rocky Mountain Gastroenterology Associates | Recruiting |
| Lakewood, Colorado, United States, 80215 | |
| Contact: James Friend 303-279-1550 james@rockymtncr.com | |
| Principal Investigator: John S Goff, MD | |
| United States, Florida | |
| Gastroenterology Group of Naples | Recruiting |
| Naples, Florida, United States, 34102 | |
| Contact: Lorie Sonstein 239-649-1336 lsonsteinresearch@embarqmail.com | |
| Principal Investigator: Raymond W Phillips, MD | |
| Shafran Gastroenterology Center | Recruiting |
| Winter Park, Florida, United States, 32789 | |
| Contact: Peggy Galvis 407-629-8121 PeggaL7@aol.com | |
| Principal Investigator: Ira Shafran, MD | |
| United States, Georgia | |
| Gastroenterology Associates of Central Georgia | Recruiting |
| Macon, Georgia, United States, 31210 | |
| Contact: Toni Broach 478-464-2600 twilkinson@gaocg.com | |
| Principal Investigator: Shahriar Sedghi, MD | |
| United States, Illinois | |
| University of Chicago Hospital Medical Center | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Kristi Milam 773-834-8489 kmilam@medicine.bsd.uchicago.edu | |
| Principal Investigator: Stephen B Hanauer, MD | |
| United States, Kentucky | |
| University of Louisville School of Medicine | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Suzanne Mann 502-852-1919 sbmann01@louisville.edu | |
| Principal Investigator: Gerald Dryden, MD | |
| United States, Maryland | |
| Metropolitan Gastroenterology Group. PC | Recruiting |
| Chevy Chase, Maryland, United States, 20815 | |
| Contact: Jennifer Bell 301-652-5520 jennifer.bell@capitaldigestivecare.com | |
| Principal Investigator: Robert Hardi, MD | |
| Endoscopic Microsurgery Associates PA | Recruiting |
| Towson, Maryland, United States, 21204 | |
| Contact: Jennifer Hudgins 410-494-1846 jhudgins@gastro-doc.com | |
| Principal Investigator: Mark D Noar, MD | |
| United States, Michigan | |
| Clinical Research Institute of Michigan | Recruiting |
| Chesterfield, Michigan, United States, 48047 | |
| Contact: Aaron Ryder 586-598-3329 aryder@researchmi.com | |
| Principal Investigator: Ronald Fogel, MD | |
| Center for Digestive Health | Recruiting |
| Troy, Michigan, United States, 48098 | |
| Contact: Susan Colar 248-267-8485 scolar@troygastro.com | |
| Principal Investigator: Sante Bologna, MD | |
| United States, Mississippi | |
| Digestive Health Center | Recruiting |
| Ocean Springs, Mississippi, United States, 39564 | |
| Contact: LuAn Brown 228-872-7612 lbrowndhc@yahoo.com | |
| Principal Investigator: Alfred E McNair, MD | |
| United States, Missouri | |
| St. Louis Center for Clinical Research | Recruiting |
| St. Louis, Missouri, United States, 63128 | |
| Contact: Melissa Parker 314-543-5225 | |
| Principal Investigator: James W Dimitroff, MD | |
| United States, New York | |
| Long Island Clinical Research Associates, LLP | Recruiting |
| Great Neck, New York, United States, 11021 | |
| Contact: Heather Dufficy 516-466-1051 hdufficy@liclinical.com | |
| Principal Investigator: Seymour Katz, MD | |
| United States, Ohio | |
| Consultants for Clinical Research | Recruiting |
| Cincinnati, Ohio, United States, 45219 | |
| Contact: Kim Lyons 513-872-4549 klyons@ccrstudy.com | |
| Principal Investigator: Terrance O'Toole, MD | |
| Ohio Gastroenterology and Liver | Recruiting |
| Cincinnati, Ohio, United States, 45014 | |
| Contact: Deb Gilbert 513-860-4801 dgilbert@ccrstudy.com | |
| Principal Investigator: Terry R Kaylor, MD | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84132-2410 | |
| Contact: Laura Vinson 801-587-9854 laura.vinson@hsc.utah.edu | |
| Principal Investigator: Kathryn A Peterson, MD | |
| Study Director: | Shunji Mochida, Ph.D. | Tsumura USA |
More Information
| Responsible Party: | Tsumura USA |
| ClinicalTrials.gov Identifier: | NCT01388933 History of Changes |
| Other Study ID Numbers: | TU100P2T2 |
| Study First Received: | July 5, 2011 |
| Last Updated: | May 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Crohn's Disease natural herbal Kampo |
inflammatory bowel disease Adult ages 18 to 75 Male and female subjects |
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |