NCT00369694

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

September 25, 2008

Status Verified

September 1, 2008

Enrollment Period

1.9 years

First QC Date

August 24, 2006

Last Update Submit

September 24, 2008

Conditions

HemorrhageEsophageal VaricesPortal Hypertension

Keywords

Esophageal varicesPortal HypertensionMelenaHematemesisGastrointestinal HemorrhageTerlipressinEfficacySafety

Outcome Measures

Primary Outcomes (1)

  • Variceal Re-bleed

    120 hours (5 Days)

Secondary Outcomes (3)

  • All cause 30 days mortality

    30 days

  • 30 days rebleed

    30 days from index bleed

  • Safety of Terlipressin

    In Hospital safety

Study Arms (2)

1

ACTIVE COMPARATOR

72 hours of Terlipressin

Drug: Terlipressin

2

PLACEBO COMPARATOR

24 hours of Terlipressin \& then next 48 hours of Dummy of Terlipressin

Drug: Terlipressin & then Dummy

Interventions

TerlipressinDRUG

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

Also known as: Novapressin
1
Terlipressin & then DummyDRUG

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

Also known as: Novapressin
2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute esophageal variceal bleed
  • Liver cirrhosis
  • Child's score \</= 11

You may not qualify if:

  • Patient on Mechanical ventilator and or ionotropic support
  • Active angina, Recent Myocardial infarction or dynamic EKG changes
  • Failure to control variceal bleed on initial endoscopy
  • Gastric variceal bleed
  • Spontaneous bacterial peritonitis at presentation
  • Hepatocellular carcinoma or other liver metastatic malignancy
  • Portal vein thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

HemorrhageEsophageal and Gastric VaricesHypertension, PortalMelenaHematemesisGastrointestinal Hemorrhage

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesLiver DiseasesVomitingSigns and Symptoms, DigestiveSigns and Symptoms

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Saeed S Hamid, FRCP, FACG

    The Aga Khan University Hospital

    STUDY CHAIR

  • Zahid SM Azam, MBBS, FCPS

    The Aga Khan University Hospital

    STUDY DIRECTOR

  • Wasim SM Jafri, FRCP, FACG

    The Aga Khan University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2006

First Posted

August 29, 2006

Study Start

August 1, 2006

Primary Completion

July 1, 2008

Study Completion

August 1, 2008

Last Updated

September 25, 2008

Record last verified: 2008-09

Locations

PA(1)