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

NCT01188733 | Completed Phase 1 DMC

• 1 other identifier: 10-005739
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cirrhosis; Portal Hypertension; Esophageal Varices

Keywords

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

Study Arms (3)

Sandostatin LAR 10mg

EXPERIMENTAL

Sandostatin LAR ( long-acting octreotide) administered every 28 days in a dose of 10mg

Drug: Long acting octreotide 10mg

Sandostatin LAR 30mg

EXPERIMENTAL

Comparison of drug doses

Drug: Long acting Octreotide 30mg

Saline

PLACEBO COMPARATOR

Saline control

Drug: Saline

Interventions

Long acting octreotide 10mg DRUG

Comparison of different doses

Also known as: Long-acting octreotide

Sandostatin LAR 10mg

Long acting Octreotide 30mg DRUG

Comparison of drug doses

Sandostatin LAR 30mg

Saline DRUG

Comparison of drug doses

Saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• presence of small esophageal varices, defined as varices \< 5 mm in diameter, without red signs documented on endoscopy within 3 months of enrollment
• age ≥ 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

MeSH Terms

Conditions

Fibrosis; Hypertension, Portal; Esophageal and Gastric Varices; Varicose Veins

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 25, 2010
• Study Start: June 1, 1998
• Primary Completion: July 1, 2000
• Study Completion: December 1, 2000
• Last Updated: August 25, 2010

Record last verified: 2010-08