Skip to content

Trial · Interventional

CompletedPhase 4Results postedRegistry data

Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding

NCTNCT00966355 (opens ClinicalTrials.gov in a new tab)Other idTPSTOT
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
1,034 participants (actual)
Sponsor
Korea University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

South Korea

Start
Sept 2006
Primary completion
May 2010
Completion
May 2010
First posted
26 Aug 2009 (estimated)
Last update posted
19 Mar 2018
Conditions
Variceal Bleeding, Cirrhosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008200920102011
  1. Ph 4

    Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding

    NCT00966355

    Sept 2006 to May 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TerlipressinDrug
  • SomatostatinDrug
  • OctreotideDrug

Arms3

  • Active comparator

    Terlipressin

    treat with terlipressin IV for 5 days and endoscopic treatment

  • Active comparator

    Somatostatin

    treat with somatostatin IV for 5 days and endoscopic treatment

  • Active comparator

    Octreotide

    treat with octreotide IV for 5 days and endoscopic treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)

    Time frame · 5 days after enrollment

Secondary outcomes(1)

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

    Time frame · 5 days after enrollment

    Registry description

    at least one of the three criteria

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 5 days after enrollment

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

GroupValue (participants)
Octreotide218
Somatostatin216
Terlipressin225
Secondary and other outcome results(1)
Secondary outcomeNumber· 5 days after enrollment

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

GroupValue (participants)
Octreotide113
Somatostatin115
Terlipressin114

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Octreotidetreat with octreotide IV for 5 days and endoscopic treatment Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days–0 / 2603 / 260
Somatostatintreat with somatostatin IV for 5 days and endoscopic treatment Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days–0 / 2593 / 259
Terlipressintreat with terlipressin IV for 5 days and endoscopic treatment Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days–0 / 2614 / 261

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 16 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

PepBank is a research reference. Talk to a doctor before you use any peptide.