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

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ClinicalTrials.gov Identifier: NCT00966355
Recruitment Status : Unknown
Verified August 2009 by Korea University.
Recruitment status was:  Recruiting
First Posted : August 26, 2009
Last Update Posted : August 26, 2009
Information provided by:
Korea University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Variceal Bleeding, Cirrhosis Drug: Terlipressin Drug: Somatostatin Drug: Octreotide Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 822 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2006
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Terlipressin
treat with terlipressin IV for 5 days and endoscopic treatment
Drug: Terlipressin
loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days
Active Comparator: Somatostatin
treat with somatostatin IV for 5 days and endoscopic treatment
Drug: Somatostatin
loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days
Active Comparator: Octreotide
treat with octreotide IV for 5 days and endoscopic treatment
Drug: Octreotide
loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days

Primary Outcome Measures :
  1. 5-day treatment failure (failure to control bleeding, rebleeding, or death) [ Time Frame: 5 days after enrollment ]

Secondary Outcome Measures :
  1. • Proportion of active bleeding during first endoscopic examination • Blood units transfused for 5 days • Adverse effects [ Time Frame: 5 days after enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966355

Contact: Soon Ho Um, Prof 82-2-920-5019 umsh@korea.ac.kr
Contact: Yeon Seok Seo, MD 82-2-920-6608 drseo@korea.ac.kr

Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Yeon Seok Seo, MD    82-2-920-6608    drseo@korea.ac.kr   
Sponsors and Collaborators
Korea University
Principal Investigator: Soon Ho Um, Prof Korea University

Responsible Party: Liver Cirrhosis Clinical Research Center, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT00966355     History of Changes
Other Study ID Numbers: TPSTOT
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: August 26, 2009
Last Verified: August 2009

Keywords provided by Korea University:
Cirrhosis, Esophagus Disorders, Varicose Veins

Additional relevant MeSH terms:
Pathologic Processes
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antihypertensive Agents
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents