NCT00317369

Brief Summary

The purpose of this study to examine the safety and efficacy of OPC-6535 and determine its optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) or in combination with a fixed oral dose of 5-ASA and enteral nutrition in patients with active Crohn's disease.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

April 21, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2007

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
13.6 years until next milestone

Results Posted

Study results publicly available

February 15, 2021

Completed
Last Updated

February 15, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

April 21, 2006

Results QC Date

January 5, 2021

Last Update Submit

January 26, 2021

Conditions

Crohn Disease

Keywords

OPC-6535Crohn's disease

Outcome Measures

Primary Outcomes (1)

  • Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug 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 (7)

  • Clinical Improvement Rate After 2 and 4 Weeks of Study Drug Administration

    Week 2, Week 4

  • Remission Rate (Number of Patients Showing Remission/Number of Patients Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration

    Week 2, Week 4，Week 8

  • Clinical Improvement Rate (50) by Change in Total CDAI Score (Number of Subjects for Each Change/Number of Subjects Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration

    Baseline, Weeks 2, 4, and 8

  • Mean Change From Baseline in Total CDAI Score After 2, 4, and 8 Weeks of Study Drug Administration

    Baseline, Weeks 2, 4, and 8

  • Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration

    Baseline, Week 8

  • +2 more secondary outcomes

Interventions

OPC-6535(Tetomilast)DRUG

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with active Crohn's disease
  • Patients who have a primary lesion in either the small intestine or the large intestine
  • Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose
  • Patients who have either never received enteral nutrition or have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less
  • Either inpatient or outpatient

You may not qualify if:

  • Patients who have an external fistula (including anal fistula) in which persistent drainage is observed (and who require treatment with antibiotics or synthetic antibacterial agents)
  • Patients with short bowel syndrome (and who require intravenous nutritional support due to insufficient intestinal nutrient uptake)
  • Patients with an artificial anus
  • Patients who have a complication of serious infectious disease (intra-abdominal abscess, etc.)
  • Patients who have a complication of malignant tumor
  • Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

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

Shikoku Region, Japan

Location

Unknown Facility

Touhoku Region, Japan

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

    Study Director, Division of New Product Evaluation and Development

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 21, 2006

First Posted

April 24, 2006

Study Start

May 1, 2006

Primary Completion

July 11, 2007

Study Completion

August 1, 2007

Last Updated

February 15, 2021

Results First Posted

February 15, 2021

Record last verified: 2021-01

Locations

JP(8)