NCT01801228

Brief Summary

This study compares Spironolactone, a non-selective aldosterone antagonist, with Eplerenone, a selective aldosterone antagonist, regarding efficacy and hormonal side effects when treating male cirrhotic patients with uncomplicated ascites over a 6 month period. The investigators hypothesis is that Eplerenone is as effective as Spironolactone as treatment of ascites with less side effects such as painful gynecomastia.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

2.7 years

First QC Date

February 26, 2013

Last Update Submit

January 14, 2016

Conditions

AscitesCirrhosis

Outcome Measures

Primary Outcomes (1)

  • Ascites

    6 months

Study Arms (2)

Eplerenone

EXPERIMENTAL

oral daily treatment with doses 100 to 400 mg

Drug: Eplerenone

Spironolactone

ACTIVE COMPARATOR

oral daily treatment with doses 100 to 400 mg

Drug: Eplerenone

Interventions

EplerenoneDRUG
EplerenoneSpironolactone

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male Ascites Cirrhosis

You may not qualify if:

  • Prior treatment with aldosterone antagonist Uncontrolled heart disease or diabetes Current malignancy Current medication interacting with aldosterone antagonists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Skane

Lund, Skåne County, 221 85, Sweden

Location

MeSH Terms

Conditions

AscitesFibrosis

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gastroenterologist

Study Record Dates

First Submitted

February 26, 2013

First Posted

February 28, 2013

Study Start

February 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations

SE(1)