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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00659802
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : September 6, 2012
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: HMPL-004 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. clinical response [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. safety [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have active confirmed mild to moderate ulcerative colitis

Exclusion Criteria:

  • Diagnosed with Crohn's Disease or

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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT00659802    
Other Study ID Numbers: HMPL-004-US-02
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: September 6, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases