Phase II Study of HMPL-004 in Patients With Ulcerative Colitis
NCT ID: NCT00659802
Last Updated: 2020-07-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
224 participants
INTERVENTIONAL
2008-02-07
2009-10-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis
NCT01805791
Phase II Study of HMPL-004 in Subjects With Crohn's Disease
NCT00655733
HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis
NCT01882764
Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis
NCT05486104
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
NCT02958865
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
placebo
Matching dose of placebo will be given orally in capsules three times per day for 56 days.
Placebo
Matching dose of Placebo
HMPL-004 low dose
A total of 1200 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days.
HMPL-004 low dose
HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).
HMPL-004 high dose
A total of 1800 mg of HMPL-004 per day in three divided doses will be given orally in capsules, 200 mg each, for 56 days.
HMPL-004 high dose
HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HMPL-004 low dose
HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).
Placebo
Matching dose of Placebo
HMPL-004 high dose
HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hutchison Medipharma Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HMPL-004-US-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.