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Completed

NCT Number: NCT00966355

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

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.

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Key information

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Anam Hospital

Seoul, 136-705, South Korea

About this study

In patients who are suspected to have variceal bleedings, pharmacologic therapy with vasoactive drugs such as terlipressin, somatostatin, and octreotide is recommended as soon as possible, even before endoscopy. However, it is still unclear whether the efficacies of these drugs are same or not. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terlipressin

Drug

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

Other names: Glypressin

Somatostatin

Drug

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

Other names: Somatosan

Octreotide

Drug

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

Other names: Sandostatin

Primary outcomes

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

    Time frame: 5 days after enrollment

Secondary outcomes

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

    Time frame: 5 days after enrollment

    at least one of the three criteria

Sponsors and collaborators

Lead sponsor

Korea University

Other

Registry information

Official study title

RCT for the Effect of Early Administration of Vasoactive Substances When Combined With Endoscopic Treatment in Acute Gastro-esophageal Variceal Bleeds: Comparisons Among Terlipressin, Somatostatin, and Octreotide

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Aug 26, 2009
Registry last updated
Mar 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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