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

August 24, 2010 updated by: Mayo Clinic

Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2
  • Phase 1

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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: Prevention
  • Allocation: Randomized
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sandostatin LAR 10mg
Sandostatin LAR ( long-acting octreotide) administered every 28 days in a dose of 10mg
Drug: Long acting octreotide 10mg
Comparison of different doses
Other Names:
  • Long-acting octreotide
Experimental: Sandostatin LAR 30mg
Comparison of drug doses
Drug: Long acting Octreotide 30mg
Comparison of drug doses
Placebo Comparator: Saline
Saline control
Drug: Saline
Comparison of drug doses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

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

June 1, 1998

Primary Completion (Actual)

July 1, 2000

Study Completion (Actual)

December 1, 2000

Study Registration Dates

First Submitted

August 23, 2010

First Submitted That Met QC Criteria

August 24, 2010

First Posted (Estimate)

August 25, 2010

Study Record Updates

Last Update Posted (Estimate)

August 25, 2010

Last Update Submitted That Met QC Criteria

August 24, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-005739

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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