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

NCT00659802 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2020-07-22

Study results available
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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.

Conditions

Interventions

DRUG

HMPL-004 low dose

HMPL-004, 400 mg (2 x 200 mg) t.i.d. (total of 1200 mg/day).

DRUG

Placebo

Matching dose of Placebo

DRUG

HMPL-004 high dose

HMPL-004, 600 mg (3 x 200 mg) t.i.d. (total of 1800 mg/day).

Sponsors & Collaborators

  • Hutchison Medipharma Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-07
Primary Completion
2009-10-13
Completion
2009-10-13

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00659802 on ClinicalTrials.gov