Status:
COMPLETED
An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with active ulcerati...
Eligibility Criteria
Inclusion
- Patients with active ulcerative colitis
- Patients having an insufficient response to ASA oral formulation: (1) Patients whose ongoing use of ASA oral formulation from ≥2 weeks prior to the day before registration is fixed at mesalazine ≥2 g/day or salazosulfapyridine 3-6 g/day, (2) Patients with continuous bloody stools from ≥2 weeks prior to the day before registration, (3) Patients whose DAI subscores are ≥2 points for "bloody stools" and ≥2 points for "endoscopic findings"
- Patients shown via colonoscopy to have major lesions between the sigmoid colon and rectum (with lesions not extending beyond the splenic flexure)
- Outpatients
Exclusion
- Patients who have a history of intestinal resection (other than appendiceal resection)
- Patients who have a complication of malignant tumor
- Female patients who are pregnant, lactating, or possibly pregnant, or who hope to become pregnant during the study period
- Patients who have complications of serious cardiac, hepatic or renal impairment
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00463151
Start Date
June 1 2007
End Date
August 1 2008
Last Update
July 20 2021
Active Locations (5)
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1
Chubu Region, Japan
2
Chugoku Region, Japan
3
Hokkaido Region, Japan
4
Kinki Region, Japan