| Trial ID: | L0618 |
| Source ID: | EUCTR2013-004605-38-AT
|
| Associated Drug: |
Norursodeoxycholic acid
|
| Title: |
Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of non-alcoholic fatty liver disease (NAFLD) - Norursodeoxycholic acid vs. Placebo in NAF
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic fatty liver disease (NAFLD) <br>MedDRA version: 17.1
Level: LLT
Classification code 10029530
Term: Non-alcoholic fatty liver
System Organ Class: 100000004871
;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
|
| Interventions: |
<br>Product Name: Norursodeoxycholic acid <br>Product Code: norUDCA<br>Pharmaceutical Form: Capsule<br>INN or Proposed INN: Norursodeoxycholic acid<br>CAS Number: 99697-24-2<br>Current Sponsor code: norUDCA<br>Other descriptive name: NOR-URSODEOXYCHOLIC A
|
| Outcome Measures: |
Main Objective: To evaluate the efficacy of two doses of norursodeoxycholic acid (norUDCA) vs. placebo for the treatment of NAFLD with or without diabetes mellitus type 2<br>;Secondary Objective: To identify efficacious norUDCA dose for the treatment of NAFLD for further evaluation in phase III;Primary end point(s): primary endpoint is the change in serum alanine aminotransferase (ALT);Timepoint(s) of evaluation of this end point: End of treatment (after 12 weeks)Secondary end point(s): s-AST, ALT, GGT at each study visit<br>ALT/AST ratio at each study visit;Timepoint(s) of evaluation of this end point: End of treatment (after 12 weeks), some endpoints additionally at each visit
|
| Sponsor/Collaborators: |
Dr. Falk Pharma GmbH
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Phase 2
|
| Enrollment: |
195
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: yes
Other specify the comparator: Two diffferent d
|
| Start Date: |
02/12/2014
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
14 November 2016
|
| Locations: |
Austria;Germany
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004605-38
|
