Clinical Trial Details

Trial ID: L0280
Source ID: NCT01154985
Associated Drug: EPA-E
Title: Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)
Acronym: --
Status: Completed
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT01154985/results
Conditions: Steatohepatitis
Interventions: Drug: Placebo capsule|Drug: EPA-E 300 mg capsule
Outcome Measures: Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies|Alanine Transaminase (ALT) Levels
Sponsor/Collaborators: Mochida Pharmaceutical Company, Ltd.
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 243
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
Start Date: June 2010
Completion Date: October 2012
Results First Posted: November 20, 2014
Last Update Posted: November 20, 2014
Locations: Mochida Investigative Site, Dothan, Alabama, United States|Mochida Investigative Site, Tucson, Arizona, United States|Mochida Investigative Site, Anaheim, California, United States|Mochida Investigative Site, Coronado, California, United States|Mochida Investigative Site, LaJolla, California, United States|Mochida Investigative Site, Los Angeles, California, United States|Mochida Investigative Site, San Diego, California, United States|Mochida Investigative Site, San Diego, California, United States|Mochida Investigative Site, Littleton, Colorado, United States|Mochida Investigative Site, Hialeah, Florida, United States|Mochida Investigative Site, Chicago, Illinois, United States|Mochida Investigative Site, Lexington, Kentucky, United States|Mochida Investigative Site, New Orleans, Louisiana, United States|Mochida Investigative Site, Chevy Chase, Maryland, United States|Mochida Investigative Site, Detroit, Michigan, United States|Mochida Investigative Site, Plymouth, Minnesota, United States|Mochida Investigative Site, Jackson, Mississippi, United States|Mochida Investigative Site, Tupelo, Mississippi, United States|Mochida Investigative Site, Plainview, New York, United States|Mochida Investigative Site, Asheville, North Carolina, United States|Mochida Investigative Site, Durham, North Carolina, United States|Mochida Investigative Site, Cincinnati, Ohio, United States|Mochida Investigative Site, Cincinnati, Ohio, United States|Mochida Investigative Site, Cleveland, Ohio, United States|Mochida Investigative Site, Providence, Rhode Island, United States|Mochida Investigative Site (2 sites), Germantown, Tennessee, United States|Mochida Investigative Site, Nashville, Tennessee, United States|Mochida Investigative Site, Houston, Texas, United States|Mochida Investigative Site (2 sites), Houston, Texas, United States|Mochida Investigative Site, San Antonio, Texas, United States|Mochida Investigative Site, Newport News, Virginia, United States|Mochida Investigative Site, Richmond, Virginia, United States|Mochida Investigative Site, Seattle, Washington, United States|Mochida Investigative Site, San Juan, Puerto Rico
URL: https://ClinicalTrials.gov/show/NCT01154985

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D124 EPA-E Chemical drug -- DGAT1 inhibitor; PLA2 inhibitor Antiinflammatory agent; Neuroprotective drug Failed in clinical trials Details
D199 L-alanine Chemical drug DB00160 KYNU -- Failed in clinical trials Details
D316 S-adenosyl-L-methionine Chemical drug DB00118 GNMT cofactor Antiviral Under clinical trials Details