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

This study has been completed.
Information provided by:
R&R Inc. Identifier:
First received: December 28, 2006
Last updated: May 25, 2008
Last verified: May 2008
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.

Condition Intervention Phase
Crohn's Disease Drug: RR110 (Tamibarotene) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of RR110 in Patients With Active Crohn's Disease

Resource links provided by NLM:

Further study details as provided by R&R Inc.:

Primary Outcome Measures:
  • Change in Crohn's disease active index (CDAI) score [ Time Frame: 8 weeks ]

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

Estimated Enrollment: 24
Study Start Date: December 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 mg RR110
1 mg RR110
Drug: RR110 (Tamibarotene)
1 mg RR110
Other Names:
  • Tamibarotene
  • Am80
Experimental: 4 mg RR110
4 mg RR110
Drug: RR110 (Tamibarotene)
4 mg RR110
Other Names:
  • Tamibarotene
  • Am80


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00417391

Toyohashi, Aichi, Japan
Sakura, Chiba, Japan
Sapporo, Hokkaido, Japan
Nishinomiya, Hyogo, Japan
Fujisawa, Kanagawa, Japan
Nakagami, Okinawa, Japan
Otsu, Shiga, Japan
Shinjuku, Tokyo, Japan
Sponsors and Collaborators
R&R Inc.
Study Chair: Toshifumi Hibi, M.D., Ph.D. Keio University School of Medicine
  More Information

Responsible Party: Miwako Ishido/Manager, R&R Inc. Identifier: NCT00417391     History of Changes
Other Study ID Numbers: 1101-01
Study First Received: December 28, 2006
Last Updated: May 25, 2008

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on August 21, 2017