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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188733
• Other study ID #: 10-005739
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 23, 2010
• Last updated: August 24, 2010
• Start date: June 1998
• Est. completion date: December 2000

Study information

• Verified date: August 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2000
• Est. primary completion date: July 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cirrhosis
• Esophageal Varices
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Drug:
• Long acting octreotide 10mg
Comparison of different doses
• Long acting Octreotide 30mg
Comparison of drug doses
• Saline
Comparison of drug doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic