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The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed
Plain-language guide to NCT00534677: phase 4 randomized trial of Octreotide and Terlipressin, 320 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00534677
- Phase
- phase 4
- Status
- completed
- Start
- 2004-05
- Completion (planned or actual)
- 2005-07
- Participants
- 320 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Portal Hypertension; Cirrhosis; Hematemesis; Melena
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Octreotide and Terlipressin.
Terlipressin and Octreotide are two common agents used as adjuvants in the management of variceal bleeding.
Both agents have been claimed equivalent to endoscopic therapy in randomized studies.
There are no head to head clinical trials of these two agents available in the literature.
It had two arms (groups): A (active comparator) and B (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 320 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: All cirrhotic patients with upper GI bleed secondary to esophageal varices of 18 years or more of age.
The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: ulcerative esophagitis,; mallory weiss tear,; bleeding gastric or duodenal ulcers,.
How the Study Was Run
It was run as a randomized, parallel-group and triple-blind study.
Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.
The Octreotide group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Octreotide, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2004-05 with completion listed for 2005-07.
It ran at 1 site in Pakistan.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Octreotide and Terlipressin in 320 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.