NCT00417391

Brief Summary

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics profile of 1 and 4 mg/kg/day RR110 administrated orally for 8 weeks in patients with active Crohn's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

8 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

December 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 29, 2008

Status Verified

May 1, 2008

Enrollment Period

1.4 years

First QC Date

December 28, 2006

Last Update Submit

May 25, 2008

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Change in Crohn's disease active index (CDAI) score

    8 weeks

Secondary Outcomes (4)

  • Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline

    8 weeks

  • Rate of clinical remission as defined by CDAI < 150

    8 weeks

  • Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores

    10 weeks

  • Safety parameters

    10 weeks

Study Arms (2)

1 mg RR110

EXPERIMENTAL

1 mg RR110

Drug: RR110 (Tamibarotene)

4 mg RR110

EXPERIMENTAL

4 mg RR110

Drug: RR110 (Tamibarotene)

Interventions

RR110 (Tamibarotene)DRUG

1 mg RR110

Also known as: Tamibarotene, Am80
1 mg RR110

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with CDAI score ranging from 220 to 450
  • Patients with CRP \> 1 mg/dL
  • Patients who can be hospitalized at least 2 weeks after first administration

You may not qualify if:

  • Patients who have previously used anti-TNF antibody, cyclosporine, methotrexate or tacrolimus within 12 weeks of screening
  • Patients who have had surgical bowel resections within 4 weeks of screening
  • Patients who have previously used total parental nutrition or more than 900 kcal/day of enteral nutrition within 4 weeks of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Toyohashi, Aichi-ken, Japan

Location

Unknown Facility

Sakura, Chiba, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Nishinomiya, Hyōgo, Japan

Location

Unknown Facility

Fujisawa, Kanagawa, Japan

Location

Unknown Facility

Nakagami, Okinawa, Japan

Location

Unknown Facility

Ōtsu, Shiga, Japan

Location

Unknown Facility

Shinjuku, Tokyo, Japan

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

N2,N6-bis(4-(2-aminoethoxy)quinolin-2-yl)-4-((4-fluorobenzyl)oxy)pyridine-2,6-dicarboxamidetamibarotene

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Toshifumi Hibi, M.D., Ph.D.

    Keio University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 28, 2006

First Posted

January 1, 2007

Study Start

December 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

May 29, 2008

Record last verified: 2008-05

Locations

JP(8)