Phase 4
N=1,034
Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding
Variceal Bleeding, Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT00966355 ↗Enrolled (actual)
1,034
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: 5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death) — 218; 216; 225 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Terlipressin (Drug); Somatostatin (Drug); Octreotide (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Korea University
- Primary completion
- May 2010
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 | — |
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.
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.