Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding

What Was Tested

In this phase 4 trial, researchers set out to test Octreotide and Somatostatin.

It had three arms (groups): Terlipressin (active comparator), Somatostatin (active comparator) and Octreotide (active comparator).

Treat with terlipressin IV for 5 days and endoscopic treatment.

Treat with somatostatin IV for 5 days and endoscopic treatment.

Treat with octreotide IV for 5 days and endoscopic treatment.

The registry classes the interventions as drug.

Who Took Part

1034 actual participants took part.

It was open to people of any sex aged from 16 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age between 16 and 75 years. Patients who have upper GI bleeding symptoms (hematemesis or melena) within 24 hours before enrollment. Patients whose systolic blood pressure \<100 mmHg or pulse rate \>100/min at the enrollment. Signed informed consent.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: positive anti-hiv ab; A history of severe side-effects or contraindications to study drugs; severe cardiovascular diseases: acute myocardial infarction, a-v block, congestive heart failure, ischemic heart disease, hypertension (systolic blood pressure \>170 mmhg or diastolic pressure \>100 mmhg).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2006-09 with completion listed for 2010-05.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide and Somatostatin in 1034 people.

With 1034 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Octreotide compound page and the Somatostatin compound page, all human trials.