NCT00534677

Brief Summary

Terlipressin and Octreotide are two common agents used as adjuvants in the management of variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in randomized studies. There are no head to head clinical trials of these two agents available in the literature. We aimed to compare the efficacy and safety of Terlipressin and Octreotide in combination with Endoscopic Variceal band Ligation (EVL)in patients presenting with Esophageal Variceal Bleed (EVB).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2004

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
Last Updated

December 5, 2007

Status Verified

September 1, 2007

First QC Date

September 24, 2007

Last Update Submit

December 4, 2007

Conditions

Portal HypertensionCirrhosisHematemesisMelena

Keywords

Variceal bleedCirrhosisVasoactive agentsTerlipressinOctreotideSafety & Efficacy

Outcome Measures

Primary Outcomes (1)

  • Safety & Efficacy

    5 days

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: Terlipressin

B

ACTIVE COMPARATOR
Drug: Octreotide

Interventions

TerlipressinDRUG

2 mg stat \& then 1 mg q6h iv and Placebo of Octreotide

Also known as: Novapresin
A
OctreotideDRUG

Octreotide 50mcg/hr infusion \& a placebo of Terlipressin

Also known as: sandostatin
B

Eligibility Criteria

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

You may qualify if:

  • All cirrhotic patients with upper GI bleed secondary to esophageal varices of 18 years or more of age

You may not qualify if:

  • Ulcerative esophagitis,
  • Mallory Weiss tear,
  • Bleeding gastric or duodenal ulcers,
  • Bleeding from gastric varices or portal hypertensive gastropathy and
  • Upper GI bleed as a result of thrombocytopenia or bleeding diathesis.

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

Hypertension, PortalFibrosisHematemesisMelena

Interventions

TerlipressinOctreotide

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal HemorrhageGastrointestinal DiseasesHemorrhageVomitingSigns and Symptoms, DigestiveSigns and Symptoms

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsPeptides, CyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Shahab Abid, FCPS, FACG

    Aga Khan University

    PRINCIPAL INVESTIGATOR

  • Wasim Jafri, FRCP, FACG

    Aga Khan University

    STUDY DIRECTOR

  • Saeed S Hamid, FRCP, FACG

    Aga Khan University

    STUDY DIRECTOR

  • Salih Mohammad, FCPS; MACG

    Aga Khan University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

May 1, 2004

Study Completion

July 1, 2005

Last Updated

December 5, 2007

Record last verified: 2007-09

Locations

PA(1)