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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01188733

Enrollment

Registered

2010-08-25

Start date

1998-06-30

Completion date

2000-12-31

Last updated

2010-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Esophageal Varices, Portal Hypertension

Keywords

portal hypertension, varices, cirrhosis, octreotide, somatostatin analog, Child Pugh Class A,B

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.

Interventions

DRUGLong acting octreotide 10mg

Comparison of different doses

DRUGLong acting Octreotide 30mg

Comparison of drug doses

DRUGSaline

Comparison of drug doses

Study design

Allocation

RANDOMIZED

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026