Trial | NCT00417391  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tamibarotene ...

  • Study Participants

    24
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.
Study Started
Dec 31
2006
Primary Completion
May 31
2008
Study Completion
May 31
2008
Last Update
May 29
2008
Estimate

Drug RR110 (Tamibarotene)

1 mg RR110

  • Other names: Tamibarotene, Am80

Drug RR110 (Tamibarotene)

4 mg RR110

  • Other names: Tamibarotene, Am80

1 mg RR110 Experimental

1 mg RR110

4 mg RR110 Experimental

4 mg RR110

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
No Results Posted