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An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00463151
First received: April 19, 2007
Last updated: February 9, 2011
Last verified: February 2011
  Purpose

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).


Condition Intervention Phase
Colitis, Ulcerative
Drug: rebamipide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Clinical improvement rate (Clinical improvement: a decrease of Disease Activity Index [DAI] score for "bloody stools" to either 0 or 1 point and a decrease of ≥1 point in the DAI score for "endoscopic findings" from the baseline) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical remission: a decrease of the total DAI scores for "bloody stools" and "endoscopic findings" to 0 points [ Time Frame: 6weeks ] [ Designated as safety issue: Yes ]
  • Changes in the total DAI score [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Changes in each DAI subscore [ Time Frame: 2, 4, 6weeks ] [ Designated as safety issue: Yes ]
  • Changes in the total Endoscopic Index (EI) score [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Changes in each EI subscore [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: June 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
0mg rebamipide
Drug: rebamipide
0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon
Experimental: 2
60mg rebamipide
Drug: rebamipide
0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon
Experimental: 3
150mg rebamipide
Drug: rebamipide
0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon
Experimental: 4
300mg rebamipide
Drug: rebamipide
0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463151

Locations
Japan
Chubu region, Japan
Chugoku region, Japan
Hokkaido region, Japan
Kinki region, Japan
Kyushu region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsuhisa Saito Division of New Product Evaluation and Development
  More Information

No publications provided

Responsible Party: Saito Katsuhisa, OPCJ
ClinicalTrials.gov Identifier: NCT00463151     History of Changes
Other Study ID Numbers: 037-06-001
Study First Received: April 19, 2007
Last Updated: February 9, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Rebamipide
Enema
Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Rebamipide
Anti-Ulcer Agents
Antioxidants
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014