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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1034 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Variceal Bleeding, Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Terlipressin

treat with terlipressin IV for 5 days and endoscopic treatment

Group Type ACTIVE_COMPARATOR

Terlipressin

Intervention Type DRUG

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

Somatostatin

treat with somatostatin IV for 5 days and endoscopic treatment

Group Type ACTIVE_COMPARATOR

Somatostatin

Intervention Type DRUG

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

Octreotide

treat with octreotide IV for 5 days and endoscopic treatment

Group Type ACTIVE_COMPARATOR

Octreotide

Intervention Type DRUG

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

Interventions

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Terlipressin

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

Intervention Type DRUG

Somatostatin

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

Intervention Type DRUG

Octreotide

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

Intervention Type DRUG

Other Intervention Names

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Glypressin Somatosan Sandostatin

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No