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

Phase 1

Completed

• Conditions: Cirrhosis; Portal Hypertension; Esophageal Varices
• Interventions: Drug: Saline; Drug: Long acting octreotide 10mg; Drug: Long acting Octreotide 30mg

• Registration Number: NCT01188733
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-06
• Primary Completion: 2000-07
• Study Completion: 2000-12
• Status Verified: 2010-08
• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-24
• Last Update Submitted: 2010-08-24
• Study First Posted: 2010-08-25
• Last Update Posted: 2010-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Saline	Saline	Saline control
Sandostatin LAR 10mg	Long acting octreotide 10mg	Sandostatin LAR ( long-acting octreotide) administered every 28 days in a dose of 10mg
Sandostatin LAR 30mg	Long acting Octreotide 30mg	Comparison of drug doses