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

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

This study is currently recruiting participants.
Verified by Hutchison Medipharma Limited, April 2008

Sponsored by:	Hutchison Medipharma Limited
Information provided by:	Hutchison Medipharma Limited
ClinicalTrials.gov Identifier:	NCT00655733

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease	Drug: HMPL004 Drug: Placebo	Phase II

Genetics Home Reference related topics:

Crohn disease

MedlinePlus related topics:

Crohn's Disease

U.S. FDA Resources

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

Further study details as provided by Hutchison Medipharma Limited:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	April 2006
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HMPL004: Experimental HMPL004 1200mg/d	Drug: HMPL004 HMPL004 1200mg/d
placebo: Placebo Comparator Placebo	Drug: Placebo 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655733

Contacts


Contact: Xiaowei Lu, MD	973-325-5668	Xiaowei.Lu@OmnicareCR.com

Locations


United States, Pennsylvania
	Omnicare Clinical Research, Inc.	Recruiting
	King of Prussia, Pennsylvania, United States, 19406
	Contact: Xiaowei Lu, MD 973-325-5668 Xiaowei.Lu@OmnicareCR.com

Sponsors and Collaborators

Hutchison Medipharma Limited

More Information

Responsible Party:	Hutchison Medipharma Limited ( Kaiyang(Tom) Tang / Vice President )
Study ID Numbers:	200500401
First Received:	April 6, 2008
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00655733
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases

Gastrointestinal Diseases

Crohn Disease

Inflammatory Bowel Diseases

Gastroenteritis

Intestinal Diseases

ClinicalTrials.gov processed this record on October 10, 2008