Status:
COMPLETED
Phase II Study of RR110 in Patients With Active Crohn's Disease
Lead Sponsor:
R&R Inc.
Conditions:
Crohn's Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00417391
Start Date
December 1 2006
End Date
May 1 2008
Last Update
May 29 2008
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Toyohashi, Aichi-ken, Japan
2
Sakura, Chiba, Japan
3
Sapporo, Hokkaido, Japan
4
Nishinomiya, Hyōgo, Japan