Short Course Terlipressin for Control of Acute Variceal Bleeding

NCT00369694 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2008-09-25

No results posted yet for this study

Summary

The purpose of this study is to determine whether 24 hours of Terlipressin is as effective as 72 hours of Terlipressin in preventing re-bleed once esophageal variceal bleed has been controlled with endoscopic therapy (variceal band ligation or sclerotherapy) in low to moderate risk variceal bleed patients and hence can save cost and may decrease length of hospital stay especially in the I.C.U or high dependency units.

Conditions

  • Hemorrhage
  • Esophageal Varices
  • Portal Hypertension

Interventions

DRUG

Terlipressin

2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours

DRUG

Terlipressin & then Dummy

2 mg Terlipressin stat then 1 mg q6 hours for 24 hours, then a Dummy of Terlipressin q6 hours for the next 48 hours.

Sponsors & Collaborators

  • Ferozsons Laboratories Ltd.

    collaborator INDUSTRY
  • Aga Khan University

    lead OTHER

Principal Investigators

  • Saeed S Hamid, FRCP, FACG · The Aga Khan University Hospital

  • Zahid SM Azam, MBBS, FCPS · The Aga Khan University Hospital

  • Wasim SM Jafri, FRCP, FACG · The Aga Khan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-07-31
Completion
2008-08-31

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

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 NCT00369694 on ClinicalTrials.gov