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OpenTrials
Completed

NCT Number: NCT01188733

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Long acting octreotide 10mg

Drug

Comparison of different doses

Other names: Long-acting octreotide

Long acting Octreotide 30mg

Drug

Comparison of drug doses

Saline

Drug

Comparison of drug doses

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2000
Study completion
2000
First posted
Aug 25, 2010
Registry last updated
Aug 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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