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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417391
• Other study ID #: 1101-01
• Status: Completed
• Phase: Phase 2
• First received: December 28, 2006
• Last updated: May 25, 2008
• Start date: December 2006
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: R&R Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• RR110 (Tamibarotene)
1 mg RR110
• RR110 (Tamibarotene)
4 mg RR110

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
R&R Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Crohn's disease active index (CDAI) score		8 weeks	No
Secondary	Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline		8 weeks	No
Secondary	Rate of clinical remission as defined by CDAI < 150		8 weeks	No
Secondary	Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores		10 weeks	No
Secondary	Safety parameters		10 weeks	Yes