An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Otsuka

Status and phase: Completed; Phase 2

Conditions: Colitis, Ulcerative

Treatments: Drug: rebamipide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00463151

037-06-001

JapicCTI-070399 (Other Identifier)

Details and patient eligibility

About

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 ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA).

Enrollment: 124 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with active ulcerative colitis
2. 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"
3. Patients shown via colonoscopy to have major lesions between the sigmoid colon and rectum (with lesions not extending beyond the splenic flexure)
4. Outpatients

Exclusion criteria

1. Patients who have a history of intestinal resection (other than appendiceal resection)
2. Patients who have a complication of malignant tumor
3. Female patients who are pregnant, lactating, or possibly pregnant, or who hope to become pregnant during the study period
4. Patients who have complications of serious cardiac, hepatic or renal impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

0mg rebamipide

Treatment:

Drug: rebamipide

2

Experimental group

Description:

60mg rebamipide

Treatment:

Drug: rebamipide

3

Experimental group

Description:

150mg rebamipide

Treatment:

Drug: rebamipide

4

Experimental group

Description:

300mg rebamipide

Treatment:

Drug: rebamipide