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
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
Benzoates
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014