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Completed

NCT Number: NCT00989573

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chubu Region, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

oral administration of placebo once-daily for 8 weeks

OPC-6535

Drug

oral administration of OPC-6535 25 mg once-daily for 8 weeks

Primary outcomes

  1. Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement / Number of Subjects Evaluated × 100) After 8 Weeks of IMP Administration

    Time frame: Week 8

    Definition of clinical improvement: Total Crohn's Disease Activity Index (CDAI) score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: remission, CDAI > 450: severe disease)

Secondary outcomes

  1. Clinical Improvement Rate After 4 Weeks of IMP Administration

    Time frame: Week 4

    Definition of clinical improvement: CDAI score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: remission, CDAI > 450: severe disease)

  2. Remission Rate (Number of Subjects Showing Remission / Number of Subjects Evaluated x 100) After 4 and 8 Weeks of IMP Administration

    Time frame: Weeks 4 and 8

    Definition of remission: Total CDAI score improved to below 150

  3. Mean Change From Baseline in C-reactive Protein (CRP) Level After 4 and 8 Weeks of IMP Administration

    Time frame: Baseline, Weeks 4 and 8

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 5, 2009
Registry last updated
Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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