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

April 6, 2008
November 4, 2012
April 2006
April 2009   (final data collection date for primary outcome measure)
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.
to investigate the efficacy of HMPL 004 given at 1200 mg/day, in producing clinical response-100 (a reduction in CDAI by at least 100 points from baseline) assessed after 8 weeks of treatment with HMPL-004 given orally three times/day for 56 days. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00655733 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase II Study of HMPL-004 in Subjects With Crohn's Disease
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
  • Drug: HMPL004
    HMPL004 1200mg/d
  • Drug: Placebo
    Placebo
  • Experimental: HMPL004
    HMPL004 1200mg/d
    Intervention: Drug: HMPL004
  • Placebo Comparator: placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00655733
200500401
No
Hutchison Medipharma Limited
Hutchison Medipharma Limited
Not Provided
Not Provided
Hutchison Medipharma Limited
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP