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A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00989573
First received: October 2, 2009
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to verify the safety and efficacy of OPC-6535 and determine the optimal dose by once-daily oral administration of OPC-6535 at 25 or 50 mg or placebo for 8 weeks in combination with base treatment (either a fixed oral dose of 5-aminosalicylic acid [5-ASA] or a fixed oral dose of 5-ASA plus enteral nutrition) in 180 patients with active Crohn's disease.


Condition Intervention Phase
Crohn's Disease
 Drug: Placebo
Drug: OPC-6535
 Phase 2
Phase 3

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: A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

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

Primary Outcome Measures:
  • Clinical improvement rate (number of subjects showing clinical improvement / number of subjects evaluated x 100) [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical improvement rate [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
  • Remission rate [ Time Frame: after 4, 8 weeks ] [ Designated as safety issue: No ]
  • Mean change in CRP level from the baseline [ Time Frame: after 4, 8 weeks ] [ Designated as safety issue: No ]
  • Clinical laboratory tests [ Time Frame: after 2, 4, 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 191
Study Start Date: October 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
oral administration of placebo once-daily for 8weeks
 Drug: Placebo
oral administration of placebo once-daily for 8 weeks
Experimental: OPC-6535 25 mg
oral administration of OPC-6535 25 mg once-daily for 8 weeks
 Drug: OPC-6535
oral administration of OPC-6535 25 mg once-daily for 8 weeks
Experimental: OPC-6535 50 mg
oral administration of OPC-6535 50mg once-daily for 8 weeks
 Drug: OPC-6535
oral administration of OPC-6535 50 mg once-daily for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary lesion in either small intestine or large intestine
  • C-reactive protein (CRP) level above the upper limit of the normal range
  • Patients who have been receiving a 5-ASA formulation (oral mesalazine) at a fixed dose of 2.25 g/day or higher (not exceeding the approved dose) and at a fixed dosing regimen
  • Patients who have not received enteral nutrition or who have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less

Exclusion Criteria:

  • Patients with an uncontrolled external fistula (including anal fistula)
  • Patients with a history of total proctocolectomy or subtotal colectomy
  • Patients with short bowel syndrome
  • Patients with an artificial anus
  • Patients with serious infectious disease (intra-abdominal abscess, etc)
  • Patients with malignant tumor
  • Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the trial period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989573

Locations
Japan
Chubu Region, Japan
Chugoku Region, Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Tohoku Region, Japan
Korea, Republic of
Busan, Korea, Republic of
Daegu, Korea, Republic of
Gyronggi-do, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Chair: Katsuhisa Saito OPCJ
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00989573     History of Changes
Other Study ID Numbers: 197-08-001, JapicCTI090915
Study First Received: October 2, 2009
Last Updated: February 19, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013