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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00655733
First Posted: April 10, 2008
Last Update Posted: December 3, 2012
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.
Information provided by (Responsible Party):
Hutchison Medipharma Limited
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hutchison Medipharma Limited:

Primary Outcome Measures:
  • The Efficacy of HMPL 004 Given at 1200 mg/Day, Assessed After 8 Weeks of Treatment With HMPL-004 in Inducing a Drop in the Subject's Crohn's Disease Activity Index (CDAI) by 100 Points. [ Time Frame: 8 weeks ]
    For the Intention to Treat (ITT) population, the Worst Observation Carried Forward (WOCF) method, was used to measure the percentage of subjects in the HMPL 004 group as compared to the placebo group that achieved a clinical response of a CDAI reduction of 100 points at Week 8 as compared to the subject's entry level CDAI score.


Secondary Outcome Measures:
  • Safety [ Time Frame: 12 weeks ]

Enrollment: 101
Study Start Date: April 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HMPL004
HMPL004 1200mg/d
Drug: HMPL004
HMPL004 1200mg/d
Placebo Comparator: placebo
Placebo
Drug: Placebo
Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
No Contacts or Locations Provided
  More Information

Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT00655733     History of Changes
Other Study ID Numbers: 200500401
First Submitted: April 6, 2008
First Posted: April 10, 2008
Results First Submitted: April 18, 2011
Results First Posted: December 3, 2012
Last Update Posted: December 3, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases