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Study to Assess the Efficacy and Safety of Somatostatin in the Treatment of Acute Severe Upper Gastrointestinal Bleeding
Plain-language guide to NCT00152399: phase 2 randomized trial of Somatostatin, 370 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00152399
- Phase
- phase 2
- Status
- completed
- Start
- 2000-09
- Completion (planned or actual)
- 2005-10
- Participants
- 370
- Design
- randomized, double-blind
- Conditions studied
- Peptic Ulcer
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Somatostatin.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 370 planned participants were the target.
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: Male or female non-cirrhotic patients at least 18 years old suspected to bleed from PU. Patients with haematemesis and/or hematochezia and/or melena which have been observed by a member of a clinical team (GP, hospital physician, nurse, ...). Either, documented signs of hypovolemia related to the current bleeding episode Or, occurrence of symptoms of hypovolemia.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: treatment of the present bleeding episode with somatostatin or its analogues, vasoactive drugs, or endoscopic therapy; any treatment with ppis (iv or per os) within the last 48 hours preceding randomisation; anticoagulant therapy (vitamin k antagonists or heparin including lmw heparins).
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Somatostatin group and the comparison group should start out alike.
The Somatostatin group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Somatostatin.
It started in 2000-09 with completion listed for 2005-10.
It ran at 22 sites in France (5), Hungary (5), Poland (4), Belgium (3), Spain (3) and Greece (2).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Somatostatin in 370 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Somatostatin compound page, all human trials.
Our Notes on the Compound
Somatostatin: A 14-amino-acid hormone that switches off the release of several other hormones, including growth hormone and insulin.
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.