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

This study is currently recruiting participants.

Verified by Hutchison Medipharma Limited, January 2009

First Received: April 8, 2008 Last Updated: January 19, 2009 History of Changes

Sponsored by:	Hutchison Medipharma Limited
Information provided by:	Hutchison Medipharma Limited
ClinicalTrials.gov Identifier:	NCT00659802

Purpose

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.

Condition	Intervention	Phase
Ulcerative Colitis	Drug: HMPL-004 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Further study details as provided by Hutchison Medipharma Limited:

Primary Outcome Measures:

clinical response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	210
Study Start Date:	March 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
placebo: Placebo Comparator placebo	Drug: Placebo Placebo
low dose: Experimental	Drug: HMPL-004 HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day), 600 mg (3 x 200 mg t.i.d. or placebo.
high dose: Experimental	Drug: HMPL-004 HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day), 600 mg (3 x 200 mg t.i.d. or placebo.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have active confirmed mild to moderate ulcerative colitis

Exclusion Criteria:

Diagnosed with Crohn's Disease or

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659802

Locations

United States, Massachusetts
Clinical Research Management, Inc.	Recruiting
Agawam, Massachusetts, United States, 01001
Contact: Gerald R McPherson, ASN, BA, CCRA 413-821-0022

Sponsors and Collaborators

Hutchison Medipharma Limited

More Information

No publications provided

Responsible Party:	Hutchison Medipharma Limited ( Kaiyang(Tom) Tang / Vice President )
Study ID Numbers:	HMPL-004-US-02
Study First Received:	April 8, 2008
Last Updated:	January 19, 2009
ClinicalTrials.gov Identifier:	NCT00659802 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases
Mesalamine
Gastrointestinal Diseases
Ulcer
Colonic Diseases

Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases

Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

ClinicalTrials.gov processed this record on July 02, 2009