Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis
Primary Purpose
Cirrhosis, Portal Hypertension, Esophageal Varices
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Long acting octreotide 10mg
Long acting Octreotide 30mg
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Cirrhosis focused on measuring portal hypertension, varices, cirrhosis, octreotide, somatostatin analog, Child Pugh Class A,B
Eligibility Criteria
Inclusion Criteria:
- 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
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Sandostatin LAR 10mg
Sandostatin LAR 30mg
Saline
Arm Description
Sandostatin LAR ( long-acting octreotide) administered every 28 days in a dose of 10mg
Comparison of drug doses
Saline control
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01188733
Brief Title
Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis
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 Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
July 2000 (Actual)
Study Completion Date
December 2000 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Portal Hypertension, Esophageal Varices
Keywords
portal hypertension, varices, cirrhosis, octreotide, somatostatin analog, Child Pugh Class A,B
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sandostatin LAR 10mg
Arm Type
Experimental
Arm Description
Sandostatin LAR ( long-acting octreotide) administered every 28 days in a dose of 10mg
Arm Title
Sandostatin LAR 30mg
Arm Type
Experimental
Arm Description
Comparison of drug doses
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline control
Intervention Type
Drug
Intervention Name(s)
Long acting octreotide 10mg
Other Intervention Name(s)
Long-acting octreotide
Intervention Description
Comparison of different doses
Intervention Type
Drug
Intervention Name(s)
Long acting Octreotide 30mg
Intervention Description
Comparison of drug doses
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Comparison of drug doses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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).
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis
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