Phase II Study of HMPL-004 in Patients With Ulcerative Colitis - Tabular View

Tracking Information
First Received Date ^ICMJE	April 8, 2008
Last Updated Date	January 19, 2009
Start Date ^ICMJE	March 2008
Estimated Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 15, 2008)	clinical response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00659802 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 15, 2008)	safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Phase II Study of HMPL-004 in Patients With Ulcerative Colitis
Official Title ^ICMJE	A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis With or Without Mesalamine
Brief Summary	The purpose of this study is to evaluate the safety and efficacy of HMPL-004 in patients with active mild to moderate ulcerative colitis (UC), compared with placebo.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Condition ^ICMJE	Ulcerative Colitis
Intervention ^ICMJE	Drug: HMPL-004 Drug: Placebo
Study Arms / Comparison Groups	Placebo Comparator: placebo
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	210
Completion Date
Estimated Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Have active confirmed mild to moderate ulcerative colitis Exclusion Criteria: Diagnosed with Crohn's Disease or
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00659802
Responsible Party	Kaiyang(Tom) Tang / Vice President, Hutchison Medipharma Limited
Study ID Numbers ^ICMJE	HMPL-004-US-02
Study Sponsor ^ICMJE	Hutchison Medipharma Limited
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Hutchison Medipharma Limited
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP