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

This study has been completed.
Sponsor:
Information provided by:
R&R Inc.
ClinicalTrials.gov Identifier:
NCT00417391
First received: December 28, 2006
Last updated: May 25, 2008
Last verified: May 2008

December 28, 2006
May 25, 2008
December 2006
May 2008   (final data collection date for primary outcome measure)
Change in Crohn's disease active index (CDAI) score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change in Crohn’s disease active index (CDAI) score
Complete list of historical versions of study NCT00417391 on ClinicalTrials.gov Archive Site
  • Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Rate of clinical remission as defined by CDAI < 150 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Safety parameters [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • 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
Not Provided
Not Provided
 
Phase II Study of RR110 in Patients With Active Crohn's Disease
Phase II Study of RR110 in Patients With Active Crohn's Disease

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn's Disease
  • Drug: RR110 (Tamibarotene)
    1 mg RR110
    Other Names:
    • Tamibarotene
    • Am80
  • Drug: RR110 (Tamibarotene)
    4 mg RR110
    Other Names:
    • Tamibarotene
    • Am80
  • Experimental: 1 mg RR110
    1 mg RR110
    Intervention: Drug: RR110 (Tamibarotene)
  • Experimental: 4 mg RR110
    4 mg RR110
    Intervention: Drug: RR110 (Tamibarotene)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00417391
1101-01
Not Provided
Miwako Ishido/Manager, R&R Inc.
R&R Inc.
Not Provided
Study Chair: Toshifumi Hibi, M.D., Ph.D. Keio University School of Medicine
R&R Inc.
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP