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

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

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

Genetics Home Reference related topics:   Crohn disease   

MedlinePlus related topics:   Ulcerative Colitis   

ChemIDplus related topics:   Mesalamine   

U.S. FDA Resources

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

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:   August 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

Responsible Party:   Hutchison Medipharma Limited ( Kaiyang(Tom) Tang / Vice President )
Study ID Numbers:   HMPL-004-US-02
First Received:   April 8, 2008
Last Updated:   April 15, 2008
ClinicalTrials.gov Identifier:   NCT00659802
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

ClinicalTrials.gov processed this record on September 05, 2008




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