Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Korea University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Korea University
ClinicalTrials.gov Identifier:
NCT00966355
First received: August 25, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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 Intervention Phase
Variceal Bleeding, Cirrhosis
Drug: Terlipressin
Drug: Somatostatin
Drug: Octreotide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Korea University:

Primary Outcome Measures:
  • 5-day treatment failure (failure to control bleeding, rebleeding, or death) [ Time Frame: 5 days after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Proportion of active bleeding during first endoscopic examination • Blood units transfused for 5 days • Adverse effects [ Time Frame: 5 days after enrollment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 822
Study Start Date: September 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966355

Contacts
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

Locations
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
Investigators
Principal Investigator: Soon Ho Um, Prof Korea University
  More Information

No publications provided

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
Study First Received: August 25, 2009
Last Updated: August 25, 2009
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Lypressin
Octreotide
Somatostatin
Terlipressin
Antidiuretic Agents
Antihypertensive Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Cardiovascular Agents
Coagulants
Gastrointestinal Agents
Hematologic Agents
Hemostatics
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 25, 2014