Phase 4
Completed N=1,034
Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding
Variceal Bleeding, Cirrhosis
Source: ClinicalTrials.gov NCT00966355 ↗
Enrolled (actual)
1,034
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: 5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death) — 218; 216; 225 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death) |
218; 216; 225 | — |
| SECONDARY Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects |
113; 115; 114 | — |
Eligibility Criteria
Inclusion Criteria
- liver cirrhosis
- 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/min at the enrollment
- Patients who were not performed endoscopic or pharmacologic therapy for varices
- Signed informed consent
Exclusion Criteria
- Pregnancy
- 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)
- Chronic renal failure
- Hepatocellular carcinoma with protal vein thrombosis
- Coexisting malignancy except hepatocellular carcinoma
Data sourced from ClinicalTrials.gov (NCT00966355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.