Phase II Study of RR110 in Patients With Active Crohn's D... | NCT00417391

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

NCT00417391

Sponsor

R&R Inc.

Status

Completed

Last Update Posted

May 29, 2008Estimated

Enrollment

24Estimated

Phase

Phase 2

Conditions

Crohn's Disease

Interventions

RR110 (Tamibarotene)
RR110 (Tamibarotene)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Dec 28, 2006

First Submission Date that Met QC Criteria

Dec 28, 2006

First Posted Date

Jan 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2008

Last Update Posted Date

May 29, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 mg RR110	Experimental	1 mg RR110	Drug: RR110 (Tamibarotene)
4 mg RR110	Experimental	4 mg RR110	Drug: RR110 (Tamibarotene)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RR110 (Tamibarotene)	Drug	1 mg RR110	1 mg RR110	Tamibarotene

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Crohn's disease active index (CDAI) score		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Rate of clinical response as defined by CDAI decrease > 70 or 100 from baseline		8 weeks
Rate of clinical remission as defined by CDAI < 150		8 weeks
Change in CRP, SAA, and fibrinogen levels, and IBDQ and CDEIS scores

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Toshifumi Hibi, M.D., Ph.D.	Keio University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Toyohashi	Aichi-ken		Japan

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C567961	N2,N6-bis(4-(2-aminoethoxy)quinolin-2-yl)-4-((4-fluorobenzyl)oxy)pyridine-2,6-dicarboxamide
C061133	tamibarotene

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided