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

Sponsor:	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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: placebo placebo	Drug: Placebo Placebo
Experimental: low dose	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.
Experimental: high dose	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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Kaiyang(Tom) Tang / Vice President, Hutchison Medipharma Limited
ClinicalTrials.gov Identifier:	NCT00659802 History of Changes
Other Study ID Numbers:	HMPL-004-US-02
Study First Received:	April 8, 2008
Last Updated:	April 18, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases

Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012