NCT00989573

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2009

Typical duration for phase_2

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
8.7 years until next milestone

Results Posted

Study results publicly available

April 6, 2021

Completed
Last Updated

April 6, 2021

Status Verified

March 1, 2021

Enrollment Period

2.8 years

First QC Date

October 2, 2009

Results QC Date

March 11, 2021

Last Update Submit

March 11, 2021

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement / Number of Subjects Evaluated Ă— 100) After 8 Weeks of IMP Administration

    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)

    Week 8

Secondary Outcomes (3)

  • Clinical Improvement Rate After 4 Weeks of IMP Administration

    Week 4

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

    Weeks 4 and 8

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

    Baseline, Weeks 4 and 8

Study Arms (3)

Placebo

PLACEBO COMPARATOR

oral administration of placebo once-daily for 8weeks

Drug: Placebo

OPC-6535 25 mg

EXPERIMENTAL

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

Drug: OPC-6535

OPC-6535 50 mg

EXPERIMENTAL

oral administration of OPC-6535 50mg once-daily for 8 weeks

Drug: OPC-6535

Interventions

PlaceboDRUG

oral administration of placebo once-daily for 8 weeks

Placebo
OPC-6535DRUG

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

OPC-6535 25 mg

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Gyronggi-do, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

tetomilast

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Results Point of Contact

Title
Director of Clinical Trials
Organization
Otsuka Pharmaceutical Co., LTD.
CL_OPCJ_RDA_Team@otsuka.jp
+81-3-6361-7366

Study Officials

  • Katsuhisa Saito

    OPCJ

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 5, 2009

Study Start

October 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

April 6, 2021

Results First Posted

April 6, 2021

Record last verified: 2021-03

Locations

KR(4)JP(7)