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Hemodynamic Effects of Terlipressin and High Dose Octreotide
Plain-language guide to NCT02119884: phase 4 randomized trial of Octreotide and Terlipressin, 88 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02119884
- Phase
- phase 4
- Status
- completed
- Start
- 2014-02
- Completion (planned or actual)
- 2016-06
- Participants
- 88 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Gastric and Esophageal Varices
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Octreotide and Terlipressin.
The purpose of the study is to find patients's response to terlipressin and octreotide during hepatic venous pressure gradient measurement by observing portal and systemic hemodynamics.
It had two arms (groups): Terlipressin group (experimental) and one (active comparator).
The registry classes the interventions as drug.
Who Took Part
88 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Gastric and Esophageal Varices have been confirmed through endoscopy. Liver Biopsy, CT or MRI indicates cirrhosis. Patients who experienced variceal bleeding.
The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: the patients who are beyond the range from 18 to 80 years old; the patients with unstable vital signs; the patients with spontaneous peritonitis or other severe infections.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Octreotide study did not mask who received what.
It started in 2014-02 with completion listed for 2016-06.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Fluctuation of HVPG (time frame: 10min, 20min and 30min after administration).
It also tracked 1 secondary outcome, for example Response Rate.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Octreotide and Terlipressin in 88 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Octreotide compound page and the Terlipressin compound page, all human trials.
Our Notes on the Compounds
Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.
Terlipressin: A synthetic vasopressin analog (Terlivaz) used for kidney failure in advanced liver disease and for variceal bleeding.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.