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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited
ClinicalTrials.gov Identifier:
NCT00655733
First received: April 6, 2008
Last updated: November 4, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT00655733     History of Changes
Other Study ID Numbers: 200500401
Study First Received: April 6, 2008
Results First Received: April 18, 2011
Last Updated: November 4, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013