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Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis

Primary Purpose

Cirrhosis, Portal Hypertension, Esophageal Varices

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Long acting octreotide 10mg
Long acting Octreotide 30mg
Saline
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cirrhosis focused on measuring portal hypertension, varices, cirrhosis, octreotide, somatostatin analog, Child Pugh Class A,B

Eligibility Criteria

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

Inclusion Criteria:

  1. Cirrhosis documented by biopsy, or suggested by characteristic features on abdominal imaging (nodular appearance, irregular contour) along with impaired synthetic liver function and thrombocytopenia and Child Turcotte Pugh Class A or B.
  2. presence of small esophageal varices, defined as varices < 5 mm in diameter, without red signs documented on endoscopy within 3 months of enrollment
  3. age ≥ 18 years

Exclusion Criteria:

  • pregnant, lactating or of child-bearing potential and not practicing acceptable method of birth control
  • allergic to sandostatin
  • high risk varices on endoscopy carried out within 3 months of assessment (large varices or red signs)
  • Child Turcotte Pugh Class C cirrhosis
  • hepatocellular carcinoma
  • evidence of ongoing alcohol or illicit drug abuse within 6 months of the study
  • serum creatinine greater than 2 mg/dL
  • platelet count below 50,000 per microliter
  • prothrombin time 4 seconds or more greater than control
  • human immunodeficiency virus (HIV) positive
  • symptomatic gallstones
  • previous history of upper gastrointestinal bleeding in the past 3 months, defined as hematemesis and/or melena
  • previous history of variceal bleeding
  • history of congestive heart failure , unstable angina, sustained ventricular tachycardia, or ventricular fibrillation
  • use of any investigational drug within 1 month prior to screening and
  • current use of beta blockers or long-acting nitrates, any other drug therapy known to have an influence on portal pressure (diuretics were allowed provided patients were on a stable dose for at least 30 days).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Sandostatin LAR 10mg

    Sandostatin LAR 30mg

    Saline

    Arm Description

    Sandostatin LAR ( long-acting octreotide) administered every 28 days in a dose of 10mg

    Comparison of drug doses

    Saline control

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 23, 2010
    Last Updated
    August 24, 2010
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01188733
    Brief Title
    Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis
    Official Title
    Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1998 (undefined)
    Primary Completion Date
    July 2000 (Actual)
    Study Completion Date
    December 2000 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Octreotide is used to control variceal bleeding. However, octreotide has to be given through the vein and is effective for less than two hours. In this study the investigators determined whether a long-acting preparation of octreotide (Sandostatin LAR)given as an intra-muscular injection every month could decrease portal pressure, and thus be used to prevent variceal bleeding in patients with cirrhosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cirrhosis, Portal Hypertension, Esophageal Varices
    Keywords
    portal hypertension, varices, cirrhosis, octreotide, somatostatin analog, Child Pugh Class A,B

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sandostatin LAR 10mg
    Arm Type
    Experimental
    Arm Description
    Sandostatin LAR ( long-acting octreotide) administered every 28 days in a dose of 10mg
    Arm Title
    Sandostatin LAR 30mg
    Arm Type
    Experimental
    Arm Description
    Comparison of drug doses
    Arm Title
    Saline
    Arm Type
    Placebo Comparator
    Arm Description
    Saline control
    Intervention Type
    Drug
    Intervention Name(s)
    Long acting octreotide 10mg
    Other Intervention Name(s)
    Long-acting octreotide
    Intervention Description
    Comparison of different doses
    Intervention Type
    Drug
    Intervention Name(s)
    Long acting Octreotide 30mg
    Intervention Description
    Comparison of drug doses
    Intervention Type
    Drug
    Intervention Name(s)
    Saline
    Intervention Description
    Comparison of drug doses

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Cirrhosis documented by biopsy, or suggested by characteristic features on abdominal imaging (nodular appearance, irregular contour) along with impaired synthetic liver function and thrombocytopenia and Child Turcotte Pugh Class A or B. presence of small esophageal varices, defined as varices < 5 mm in diameter, without red signs documented on endoscopy within 3 months of enrollment age ≥ 18 years Exclusion Criteria: pregnant, lactating or of child-bearing potential and not practicing acceptable method of birth control allergic to sandostatin high risk varices on endoscopy carried out within 3 months of assessment (large varices or red signs) Child Turcotte Pugh Class C cirrhosis hepatocellular carcinoma evidence of ongoing alcohol or illicit drug abuse within 6 months of the study serum creatinine greater than 2 mg/dL platelet count below 50,000 per microliter prothrombin time 4 seconds or more greater than control human immunodeficiency virus (HIV) positive symptomatic gallstones previous history of upper gastrointestinal bleeding in the past 3 months, defined as hematemesis and/or melena previous history of variceal bleeding history of congestive heart failure , unstable angina, sustained ventricular tachycardia, or ventricular fibrillation use of any investigational drug within 1 month prior to screening and current use of beta blockers or long-acting nitrates, any other drug therapy known to have an influence on portal pressure (diuretics were allowed provided patients were on a stable dose for at least 30 days).

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis

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