A Phase III Maintenance Placebo Controlled Maintenance Trial Of HMPL-004 in Subjects With Mild to Moderate Ulcerative Colitis (NATRUL-4)
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|ClinicalTrials.gov Identifier: NCT01882764|
Recruitment Status : Terminated
First Posted : June 20, 2013
Last Update Posted : May 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: HMPL-004 tablet Drug: Placebo Tablet||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects With Mild to Moderate Ulcerative Colitis With Clinical Remission or Response From Induction Therapy. (NATRUL-4)|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: HMPL-004 1800 mg/day
HMPL-004 600 mg tablet given t.i.d.
Drug: HMPL-004 tablet
HMPL-004 tablet given at a strength of 1800 mg/day, (600 mg t.i.d.)
Placebo Comparator: Placebo
600 mg Placebo tablet given t.i.d.
Drug: Placebo Tablet
- The Efficacy of HMPL-004 in the maintenance of clinical remission [ Time Frame: After 1 year of treatment ]The primary endpoint is the proportion of subjects who are in clinical remission after 52 weeks of maintenance treatment, following successful induction therapy to achieve clinical remission or clinical response. Clinical remission is defined as a modified Mayo Score ≤2 along with no individual score >1 AND rectal bleeding score = 0. The Mayo Scoring system used for this study has been modified to allow mild friability to be scored as a 2 (moderate disease). Clinical response is defined as a decrease in the modified Mayo Score from baseline by ≥ 3 points AND ≥ 30% decrease in the modified Mayo Score, along with either a decrease in the rectal bleeding score ≥ 1 OR an absolute rectal bleeding score ≤ 1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882764
|United States, Massachusetts|
|Clinical Research Management, Inc.|
|Agawam, Massachusetts, United States|