| Trial ID: | L0985 |
| Source ID: | NCT00160407
|
| Associated Drug: |
Orlistat
|
| Title: |
Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Fatty Liver;Hepatitis
|
| Interventions: |
Drug: Orlistat (Xenical);Behavioral: 1400 kcal diet (30% fat)
|
| Outcome Measures: |
The primary endpoint is weight loss leading to improvement in the global necroinflammatory and fibrosis scores on liver biopsies. A change of one point in the necroinflammatory grade or fibrosis stage will be considered statistically significant.BMI,ALT,Serum free fatty acids,HOMA-IR (fasting insulin x fasting glucose/22.4)
|
| Sponsor/Collaborators: |
St. Louis University
|
| Gender: |
All
|
| Age: |
18 Yearsnan
|
| Phases: |
Phase 4
|
| Enrollment: |
50
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
| Start Date: |
08/09/2005
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
19 February 2015
|
| Locations: |
United States
|
| URL: |
http://clinicaltrials.gov/show/NCT00160407
|
