NCT00966355

Brief Summary

This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,034

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_4

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

September 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
7.9 years until next milestone

Results Posted

Study results publicly available

March 19, 2018

Completed
Last Updated

March 19, 2018

Status Verified

August 1, 2017

Enrollment Period

3.7 years

First QC Date

August 25, 2009

Results QC Date

April 23, 2013

Last Update Submit

August 22, 2017

Conditions

Variceal Bleeding, Cirrhosis

Keywords

Cirrhosis, Esophagus Disorders, Varicose Veins

Outcome Measures

Primary Outcomes (1)

  • 5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)

    5 days after enrollment

Secondary Outcomes (1)

  • Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects

    5 days after enrollment

Study Arms (3)

Terlipressin

ACTIVE COMPARATOR

treat with terlipressin IV for 5 days and endoscopic treatment

Drug: Terlipressin

Somatostatin

ACTIVE COMPARATOR

treat with somatostatin IV for 5 days and endoscopic treatment

Drug: Somatostatin

Octreotide

ACTIVE COMPARATOR

treat with octreotide IV for 5 days and endoscopic treatment

Drug: Octreotide

Interventions

TerlipressinDRUG

loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days

Also known as: Glypressin
Terlipressin
SomatostatinDRUG

loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days

Also known as: Somatosan
Somatostatin
OctreotideDRUG

loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days

Also known as: Sandostatin
Octreotide

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • liver cirrhosis
  • age between 16 and 75 years
  • Patients who have upper GI bleeding symptoms (hematemesis or melena) within 24 hours before enrollment
  • Patients whose systolic blood pressure \<100 mmHg or pulse rate \>100/min at the enrollment
  • Patients who were not performed endoscopic or pharmacologic therapy for varices
  • Signed informed consent

You may not qualify if:

  • Pregnancy
  • Positive anti-HIV Ab
  • A history of severe side-effects or contraindications to study drugs
  • Severe cardiovascular diseases: acute myocardial infarction, A-V block, congestive heart failure, ischemic heart disease, hypertension (systolic blood pressure \>170 mmHg or diastolic pressure \>100 mmHg)
  • Chronic renal failure
  • Hepatocellular carcinoma with protal vein thrombosis
  • Coexisting malignancy except hepatocellular carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

MeSH Terms

Conditions

FibrosisEsophageal DiseasesVaricose Veins

Interventions

TerlipressinSomatostatinOctreotide

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsPituitary Hormone Release Inhibiting HormonesHypothalamic HormonesPancreatic HormonesPeptides, CyclicMacrocyclic CompoundsPolycyclic Compounds

Results Point of Contact

Title
Prof. Soon Ho Um
Organization
Korea University College of Medicine
umsh@korea.ac.kr
+82-2-920-5019

Study Officials

  • Soon Ho Um, Prof

    Korea University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 26, 2009

Study Start

September 1, 2006

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

March 19, 2018

Results First Posted

March 19, 2018

Record last verified: 2017-08

Locations

KR(1)