Phase II Study of RR110 in Patients With Active Crohn's Disease

May 25, 2008 updated by: R&R Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Toyohashi, Aichi, Japan
    • Chiba
      • Sakura, Chiba, Japan
    • Hokkaido
      • Sapporo, Hokkaido, Japan
    • Hyogo
      • Nishinomiya, Hyogo, Japan
    • Kanagawa
      • Fujisawa, Kanagawa, Japan
    • Okinawa
      • Nakagami, Okinawa, Japan
    • Shiga
      • Otsu, Shiga, Japan
    • Tokyo
      • Shinjuku, Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 mg RR110
Drug: RR110 (Tamibarotene)
1 mg RR110
Other Names:
  • Tamibarotene
  • Am80
Drug: RR110 (Tamibarotene)
4 mg RR110
Other Names:
  • Tamibarotene
  • Am80
Experimental: 4 mg RR110
Drug: RR110 (Tamibarotene)
1 mg RR110
Other Names:
  • Tamibarotene
  • Am80
Drug: RR110 (Tamibarotene)
4 mg RR110
Other Names:
  • Tamibarotene
  • Am80

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Crohn's disease active index (CDAI) score
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline
Time Frame: 8 weeks
8 weeks
Rate of clinical remission as defined by CDAI < 150
Time Frame: 8 weeks
8 weeks
Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores
Time Frame: 10 weeks
10 weeks
Safety parameters
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R&R Inc.

Investigators

  • Study Chair: Toshifumi Hibi, M.D., Ph.D., Keio University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

December 28, 2006

First Submitted That Met QC Criteria

December 28, 2006

First Posted (Estimate)

January 1, 2007

Study Record Updates

Last Update Posted (Estimate)

May 29, 2008

Last Update Submitted That Met QC Criteria

May 25, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1101-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn's Disease

Clinical Trials on RR110 (Tamibarotene)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe