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

This study has been completed.
Sponsor:
Information provided by:
R&R Inc.
ClinicalTrials.gov Identifier:
NCT00417391
First received: December 28, 2006
Last updated: May 25, 2008
Last verified: May 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Rate of clinical remission as defined by CDAI < 150 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Safety parameters [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00417391

Locations
Japan
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.
Investigators
Study Chair: Toshifumi Hibi, M.D., Ph.D. Keio University School of Medicine
  More Information

No publications provided

Responsible Party: Miwako Ishido/Manager, R&R Inc.
ClinicalTrials.gov Identifier: NCT00417391     History of Changes
Other Study ID Numbers: 1101-01
Study First Received: December 28, 2006
Last Updated: May 25, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 30, 2014