Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01188733
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : August 25, 2010
Sponsor:
Information provided by:
Mayo Clinic

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.


Condition or disease Intervention/treatment Phase
Cirrhosis Portal Hypertension Esophageal Varices Drug: Long acting octreotide 10mg Drug: Long acting Octreotide 30mg Drug: Saline Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : June 1998
Actual Primary Completion Date : July 2000
Actual Study Completion Date : December 2000


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 Name: 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





Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Layout table for additonal information
Responsible Party: Patrick S. Kamath, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester MN 55905
ClinicalTrials.gov Identifier: NCT01188733    
Other Study ID Numbers: 10-005739
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: August 25, 2010
Last Verified: August 2010
Keywords provided by Mayo Clinic:
portal hypertension
varices
cirrhosis
octreotide
somatostatin analog
Child Pugh Class A,B
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Cirrhosis
Hypertension, Portal
Esophageal and Gastric Varices
Hypertension
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents