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Prevention of Esophageal Varices by Beta-Adrenergic Blockers

NCT00006398 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2017-06-01

No results posted yet for this study

Summary

The purpose of this study is to learn whether timolol is useful in preventing or delaying the appearance of gastroesophageal varices, a complication that may develop in the future as a consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing through the liver. This leads to an increased pressure in the portal vein (the vein that takes blood to your liver). High portal pressure is responsible for the appearance of complications of chronic liver disease such as varices and variceal bleeding (bleeding from veins in your esophagus). Timolol belongs to a group of medications called beta-blockers. Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker pills are useful in preventing bleeding from varices in patients who already have varices. A more desirable effect would be if these pills could prevent not only bleeding from varices but the appearance of varices (and therefore of bleeding).

Conditions

Interventions

DRUG

Timolol Maleate

DRUG

Placebo

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Roberto J Groszmann, M.D. · Yale University School of Med.

  • Norman Grace, M.D. · Tufts University

  • Jaime Bosch, M.D. · University of Barcelona

  • Andrew Burroughs, M.D. · University of London

  • Guadalupe Garcia-Tsao, M.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-08-31
Primary Completion
2002-09-30
Completion
2002-09-30
FDA Drug
Yes

Countries

  • United States
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006398 on ClinicalTrials.gov