- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00966355
Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding
August 22, 2017 updated by: Soon Ho Um, Korea University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
1034
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of, 136-705
- Korea University Anam Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 73 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Terlipressin
treat with terlipressin IV for 5 days and endoscopic treatment
|
loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days
Other Names:
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Active Comparator: Somatostatin
treat with somatostatin IV for 5 days and endoscopic treatment
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loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days
Other Names:
|
Active Comparator: Octreotide
treat with octreotide IV for 5 days and endoscopic treatment
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loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)
Time Frame: 5 days after enrollment
|
5 days after enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 days after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Soon Ho Um, Prof, Korea University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
August 25, 2009
First Submitted That Met QC Criteria
August 25, 2009
First Posted (Estimate)
August 26, 2009
Study Record Updates
Last Update Posted (Actual)
March 19, 2018
Last Update Submitted That Met QC Criteria
August 22, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TPSTOT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
Taipei Veterans General Hospital, TaiwanNational Science Council, TaiwanUnknownGastric Variceal Bleeding | Liver Cirrhosis and Hepatoma.China
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-
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Clinical Trials on Terlipressin
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First Affiliated Hospital, Sun Yat-Sen UniversityCompleted
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MallinckrodtCompletedHepatorenal SyndromeUnited States
-
Ferring PharmaceuticalsCompletedGastrointestinal Bleeding | Oesophageal VaricesRomania
-
Pere GinesUnknownCirrhosis | Hepatorenal Syndrome Type ISpain
-
Assaf-Harofeh Medical CenterUnknown
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BioVie Inc.CompletedCirrhosis | Ascites HepaticUnited States
-
Aga Khan UniversityFerozsons Laboratories Ltd.CompletedHemorrhage | Portal Hypertension | Esophageal VaricesPakistan
-
Hospital Clinic of BarcelonaGrant from Education Ministery from 2001-2004.SuspendedCirrhosis | Hepatorenal SyndromeSpain
-
Aga Khan UniversityMallinckrodtUnknown
-
University of PadovaUnknownCirrhosis | Type 1 Hepatorenal SyndromeItaly