Back to results

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

Primary Purpose

Variceal Bleeding, Cirrhosis

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Terlipressin

Somatostatin

Octreotide

About this trial

This is an interventional treatment trial for Variceal Bleeding, Cirrhosis focused on measuring Cirrhosis, Esophagus Disorders, Varicose Veins

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Korea University Anam Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Terlipressin

Somatostatin

Octreotide

Arm Description

treat with terlipressin IV for 5 days and endoscopic treatment

treat with somatostatin IV for 5 days and endoscopic treatment

treat with octreotide IV for 5 days and endoscopic treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

at least one of the three criteria

Full Information

NCT ID

NCT00966355

First Posted

August 25, 2009

Last Updated

August 22, 2017

Sponsor

Korea University

1. Study Identification

Unique Protocol Identification Number

NCT00966355

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Korea University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Variceal Bleeding, Cirrhosis

Keywords

Cirrhosis, Esophagus Disorders, Varicose Veins

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1034 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Terlipressin

Arm Type

Active Comparator

Arm Description

treat with terlipressin IV for 5 days and endoscopic treatment

Arm Title

Somatostatin

Arm Type

Active Comparator

Arm Description

treat with somatostatin IV for 5 days and endoscopic treatment

Arm Title

Octreotide

Arm Type

Active Comparator

Arm Description

treat with octreotide IV for 5 days and endoscopic treatment

Intervention Type

Drug

Intervention Name(s)

Terlipressin

Other Intervention Name(s)

Glypressin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Somatostatin

Other Intervention Name(s)

Somatosan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Octreotide

Other Intervention Name(s)

Sandostatin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

5 days after enrollment

Secondary Outcome Measure Information:

Title

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

Description

at least one of the three criteria

Time Frame

5 days after enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Soon Ho Um, Prof

Organizational Affiliation

Korea University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Korea University Anam Hospital

City

Seoul

ZIP/Postal Code

136-705

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs