Back to resultsPhase II Study of RR110 in Patients With Active Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
RR110 (Tamibarotene)
RR110 (Tamibarotene)
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1 mg RR110
4 mg RR110
Arm Description
1 mg RR110
4 mg RR110
Outcomes
Primary Outcome Measures
Change in Crohn's disease active index (CDAI) score
Secondary Outcome Measures
Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline
Rate of clinical remission as defined by CDAI < 150
Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores
Safety parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00417391
Brief Title
Phase II Study of RR110 in Patients With Active Crohn's Disease
Official Title
Phase II Study of RR110 in Patients With Active Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
R&R Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 mg RR110
Arm Type
Experimental
Arm Description
1 mg RR110
Arm Title
4 mg RR110
Arm Type
Experimental
Arm Description
4 mg RR110
Intervention Type
Drug
Intervention Name(s)
RR110 (Tamibarotene)
Other Intervention Name(s)
Tamibarotene, Am80
Intervention Description
1 mg RR110
Intervention Type
Drug
Intervention Name(s)
RR110 (Tamibarotene)
Other Intervention Name(s)
Tamibarotene, Am80
Intervention Description
4 mg RR110
Primary Outcome Measure Information:
Title
Change in Crohn's disease active index (CDAI) score
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline
Time Frame
8 weeks
Title
Rate of clinical remission as defined by CDAI < 150
Time Frame
8 weeks
Title
Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores
Time Frame
10 weeks
Title
Safety parameters
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshifumi Hibi, M.D., Ph.D.
Organizational Affiliation
Keio University
Official's Role
Study Chair
Facility Information:
City
Toyohashi
State/Province
Aichi
Country
Japan
City
Sakura
State/Province
Chiba
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Nishinomiya
State/Province
Hyogo
Country
Japan
City
Fujisawa
State/Province
Kanagawa
Country
Japan
City
Nakagami
State/Province
Okinawa
Country
Japan
City
Otsu
State/Province
Shiga
Country
Japan
City
Shinjuku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
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Phase II Study of RR110 in Patients With Active Crohn's Disease
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