Variceal Bleeding, CirrhosisPhase 4NCT00966355
Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding
A Phase 4 study testing Terlipressin, Somatostatin and Octreotide in people with Variceal Bleeding, Cirrhosis, run by Korea University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Variceal Bleeding, Cirrhosis
- What is being tested?
- Terlipressin, Somatostatin and Octreotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,034 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2006to May 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 mmHg or pulse rate >100/min at the enrollment
- Patients who were not performed endoscopic or pharmacologic therapy for varices
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RCT for the Effect of Early Administration of Vasoactive Substances When Combined With Endoscopic Treatment in Acute Gastro-esophageal Variceal Bleeds: Comparisons Among Terlipressin, Somatostatin, and Octreotide
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.
Read the detailed description
In patients who are suspected to have variceal bleedings, pharmacologic therapy with vasoactive drugs such as terlipressin, somatostatin, and octreotide is recommended as soon as possible, even before endoscopy. However, it is still unclear whether the efficacies of these drugs are same or not. 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.
- Conditions
- Variceal Bleeding, Cirrhosis
- Being tested
- Terlipressin, Somatostatin, Octreotide
- Keywords
- Cirrhosis, Esophagus Disorders, Varicose Veins
- Medical subject headings
- Fibrosis, Esophageal Diseases, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Also called Glypressin
loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days
SomatostatinDrug
Also called Somatosan
loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days
OctreotideDrug
Also called Sandostatin
loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin | Active comparator | treat with terlipressin IV for 5 days and endoscopic treatment Receives: Drug: Terlipressin |
| Somatostatin | Active comparator | treat with somatostatin IV for 5 days and endoscopic treatment Receives: Drug: Somatostatin |
| Octreotide | Active comparator | treat with octreotide IV for 5 days and endoscopic treatment Receives: Drug: Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)
Measured: 5 days after enrollment
Secondary outcomes (1)
Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects
at least one of the three criteria
Measured: 5 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startSep 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Variceal Bleeding, CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soon Ho Um, Korea University
- Investigators
- Soon Ho Um, Prof, Principal investigator, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966355
- Sponsor's protocol ID
- TPSTOT
- Status last verified
- Aug 2017
- First submitted
- 25 Aug 2009
- Last updated
- 19 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT for the Effect of Early Administration of Vasoactive Substances When Combined With Endoscopic Treatment in Acute Gastro-esophageal Variceal Bleeds: Comparisons Among Terlipressin, Somatostatin, and Octreotide
- ClinicalTrials.gov ID
- NCT00966355
- Acronym / sponsor ID
- TPSTOT
- Conditions
- Variceal Bleeding, Cirrhosis
- Keywords
- Cirrhosis, Esophagus Disorders, Varicose Veins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,034 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 26 Aug 2009 (estimated)
- Results
- Posted 19 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In patients who are suspected to have variceal bleedings, pharmacologic therapy with vasoactive drugs such as terlipressin, somatostatin, and octreotide is recommended as soon as possible, even before endoscopy. However, it is still unclear whether the efficacies of these drugs are same or not. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Terlipressin | Active comparator | Drug: Terlipressintreat with terlipressin IV for 5 days and endoscopic treatment |
| Somatostatin | Active comparator | Drug: Somatostatintreat with somatostatin IV for 5 days and endoscopic treatment |
| Octreotide | Active comparator | Drug: Octreotidetreat with octreotide IV for 5 days and endoscopic treatment |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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 mmHg or pulse rate >100/min at the enrollment
- Patients who were not performed endoscopic or pharmacologic therapy for varices
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TerlipressinAlso: Glypressinloading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days | Drug | Terlipressin |
| SomatostatinAlso: Somatosanloading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days | Drug | Somatostatin |
| OctreotideAlso: Sandostatinloading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days | Drug | Octreotide |
Primary outcome
5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)
Time frame: 5 days after enrollment
1 secondary outcome
Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects
Time frame: 5 days after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soon Ho Um, Prof principal investigator
Korea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Terlipressin, Somatostatin and Octreotide in people with Variceal Bleeding, Cirrhosis, run by Korea University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death) (time frame: 5 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.