Phase II Study of RR110 in Patients With Active Crohn's Disease
NCT ID: NCT00417391
Last Updated: 2008-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2006-12-31
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1 mg RR110
1 mg RR110
RR110 (Tamibarotene)
1 mg RR110
4 mg RR110
4 mg RR110
RR110 (Tamibarotene)
4 mg RR110
Interventions
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RR110 (Tamibarotene)
1 mg RR110
RR110 (Tamibarotene)
4 mg RR110
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with CRP \> 1 mg/dL
* Patients who can be hospitalized at least 2 weeks after first administration
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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R&R Inc.
INDUSTRY
Responsible Party
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R&R Inc.
Principal Investigators
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Toshifumi Hibi, M.D., Ph.D.
Role: STUDY_CHAIR
Keio University
Locations
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Toyohashi, Aichi-ken, Japan
Sakura, Chiba, Japan
Sapporo, Hokkaido, Japan
Nishinomiya, Hyōgo, Japan
Fujisawa, Kanagawa, Japan
Nakagami, Okinawa, Japan
Ōtsu, Shiga, Japan
Shinjuku, Tokyo, Japan
Countries
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Other Identifiers
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1101-01
Identifier Type: -
Identifier Source: org_study_id