Phase II Study of HMPL-004 in Subjects With Crohn's Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hutchison Medipharma Limited

ClinicalTrials.gov Identifier:

NCT00655733

First received: April 6, 2008

Last updated: November 4, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 6, 2008
Last Updated Date	November 4, 2012
Start Date ^ICMJE	April 2006
Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 4, 2012)	The Efficacy of HMPL 004 Given at 1200 mg/Day, Assessed After 8 Weeks of Treatment With HMPL-004 in Inducing a Drop in the Subject's Crohn's Disease Activity Index (CDAI) by 100 Points. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] For the Intention to Treat (ITT) population, the Worst Observation Carried Forward (WOCF) method, was used to measure the percentage of subjects in the HMPL 004 group as compared to the placebo group that achieved a clinical response of a CDAI reduction of 100 points at Week 8 as compared to the subject's entry level CDAI score.
Original Primary Outcome Measures ^ICMJE (submitted: April 9, 2008)	to investigate the efficacy of HMPL 004 given at 1200 mg/day, in producing clinical response-100 (a reduction in CDAI by at least 100 points from baseline) assessed after 8 weeks of treatment with HMPL-004 given orally three times/day for 56 days. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00655733 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 9, 2008)	Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Phase II Study of HMPL-004 in Subjects With Crohn's Disease
Official Title ^ICMJE	Not Provided
Brief Summary	Double-blind, randomized, multicenter, placebo-controlled study The purpose of this study is to evaluate the efficacy and safety of HMPL-004 in patients with active moderate Crohn's Disease,compared with placebo.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Crohn's Disease
Intervention ^ICMJE	Drug: HMPL004 HMPL004 1200mg/d Drug: Placebo Placebo
Study Arm (s)	Experimental: HMPL004 HMPL004 1200mg/d Intervention: Drug: HMPL004 Placebo Comparator: placebo Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	101
Completion Date	April 2009
Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Have active confirmed Crohn's Disease (confirmed radiographically, endoscopic, or histologically), with a CDAI of 220-400 at baseline screen Exclusion Criteria: They have received anti-TNF-α antibody within 3 months of starting study medication, or cyclosporine, tacrolimus, thalidomide or mycophenolate mofetil within 2 months of starting study medication
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00655733
Other Study ID Numbers ^ICMJE	200500401
Has Data Monitoring Committee	No
Responsible Party	Hutchison Medipharma Limited
Study Sponsor ^ICMJE	Hutchison Medipharma Limited
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hutchison Medipharma Limited
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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