Gastrointestinal HemorrhagePhase 4KT-2000NCT00450164
Secondary Prophylaxis After Variceal Bleeding in Non-Responders
A Phase 4 study testing esofagic varices ligation, Nadolol and Isosorbide mononitrate in people with Gastrointestinal Hemorrhage and Portal Hypertension, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Controlled and randomized study comparing combined treatment (nadolol and endoscopic ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to hemodynamic response, in the prevention of esofagic verices rebleeding. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Hemorrhage, Portal Hypertension, Cirrhosis
- What is being tested?
- esofagic varices ligation, Nadolol and Isosorbide mononitrate
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2000to Jun 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any Patient with endoscopically assessed Variceal Bleeding (esofagic and gastric)
- Cirrhosis
- Patient agreement to be included in the study onsentiment signed
Who cannot join
- Any associated comorbidity with life expectancy lesser than 6 months
- Patient refusement to be included in the study.
- Pregnancy
- Failure to control acute bleeding
- Previous prophylaxis treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Secondary Prophylaxis After Variceal Bleeding: Combined Treatment With Endoscopic Ligation and Nadolol Against Nadolol Associated With Mononitrate of Isosorbide or Prazosin According to Hemodynamic Response.
Controlled and randomized study comparing combined treatment (nadolol and endoscopic ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to hemodynamic response, in the prevention of esofagic verices rebleeding.
Read the detailed description
The present is a prospective, randomized, open label study, in parallel groups, in which the patients with hemorrhage caused by esofagic varices will be randomized in two groups of treatment, after control of acute hemorrhage.
All the patients included will receive standard medical treatment with beta - blockers and endoscopic ligation of the esofagic varices.
The control group will be constituted by the patients assigned to receive endoscopic ligation and nadolol (N).
The experimental group will be constituted by patients assigned to receive treatment according to the hemodynamic response.
All patients included in the experimental group will receive pharmacologic treatment with nadolol combined with Isosorbide Mononitrate (MNI) or Prazosin (PZ).
In both groups it will practice a basal hepatic hemodynamic study in the 4th-5th day after their admitance (after achieve hemodynamic stability for at least 48 h and with hemorrhage controlled) and a second control hepatic hemodynamic study 3-4 weeks after the beginning of the pharmacologic treatment, once adjusted doses.
In the experimental group, the responders to N + MNI will keep on this treatment, but nonrespondent in the hemodynamic study will switch treatment to N + PZ and a third hepatic hemodynamic study will be performed 3 to 4 weeks after the dosage adjustement.
The randomization will be stratified according to the degree of hepatic failure measured by Child-Pugh classification (classes A and B versus C) The design is random to avoid bias in the selection of the patients.
- Conditions
- Gastrointestinal Hemorrhage, Portal Hypertension, Cirrhosis
- Being tested
- esofagic varices ligation, Nadolol, Isosorbide mononitrate, Prazosin
- Keywords
- Variceal bleeding, Secondary profilaxis, Hemodynamic, Portal hypertension
- Medical subject headings
- Gastrointestinal Hemorrhage, Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esofagic varices ligationProcedure or surgery
NadololDrug
Isosorbide mononitrateDrug
PrazosinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared efficacy (at least 6 moths of follow-up)
Secondary outcomes (2)
Mortallity
Rebleeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startNov 2000
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Investigators
- Candid - Villanueva, Dr., Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450164
- Sponsor's protocol ID
- KT-2000
- Acronym
- KT-2000
- Status last verified
- Mar 2007
- First submitted
- 20 Mar 2007
- Last updated
- 21 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prophylaxis After Variceal Bleeding: Combined Treatment With Endoscopic Ligation and Nadolol Against Nadolol Associated With Mononitrate of Isosorbide or Prazosin According to Hemodynamic Response.
- ClinicalTrials.gov ID
- NCT00450164
- Acronym / sponsor ID
- KT-2000 / KT-2000
- Conditions
- Gastrointestinal Hemorrhage, Portal Hypertension, Cirrhosis
- Keywords
- Variceal bleeding, Secondary profilaxis, Hemodynamic, Portal hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Nov 2000
- Study completion
- Jun 2004 (actual)
- First posted
- 21 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Controlled and randomized study comparing combined treatment (nadolol and endoscopic ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to hemodynamic response, in the prevention of esofagic verices rebleeding.
Detailed description
The present is a prospective, randomized, open label study, in parallel groups, in which the patients with hemorrhage caused by esofagic varices will be randomized in two groups of treatment, after control of acute hemorrhage.
All the patients included will receive standard medical treatment with beta - blockers and endoscopic ligation of the esofagic varices.
The control group will be constituted by the patients assigned to receive endoscopic ligation and nadolol (N).
The experimental group will be constituted by patients assigned to receive treatment according to the hemodynamic response.
All patients included in the experimental group will receive pharmacologic treatment with nadolol combined with Isosorbide Mononitrate (MNI) or Prazosin (PZ).
In both groups it will practice a basal hepatic hemodynamic study in the 4th-5th day after their admitance (after achieve hemodynamic stability for at least 48 h and with hemorrhage controlled) and a second control hepatic hemodynamic study 3-4 weeks after the beginning of the pharmacologic treatment, once adjusted doses.
In the experimental group, the responders to N + MNI will keep on this treatment, but nonrespondent in the hemodynamic study will switch treatment to N + PZ and a third hepatic hemodynamic study will be performed 3 to 4 weeks after the dosage adjustement.
The randomization will be stratified according to the degree of hepatic failure measured by Child-Pugh classification (classes A and B versus C) The design is random to avoid bias in the selection of the patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any Patient with endoscopically assessed Variceal Bleeding (esofagic and gastric)
- Cirrhosis
- Patient agreement to be included in the study onsentiment signed
Key exclusion criteria (5 listed)
- Any associated comorbidity with life expectancy lesser than 6 months
- Patient refusement to be included in the study.
- Pregnancy
- Failure to control acute bleeding
- Previous prophylaxis treatment
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 |
|---|---|---|
| esofagic varices ligation | Procedure or surgery | – |
| Nadolol | Drug | – |
| Isosorbide mononitrate | Drug | – |
| Prazosin | Drug | – |
Primary outcome
Compared efficacy (at least 6 moths of follow-up)
2 secondary outcomes
Mortallity
Rebleeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2007.
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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.
Candid - Villanueva, Dr. principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 esofagic varices ligation, Nadolol and Isosorbide mononitrate in people with Gastrointestinal Hemorrhage and Portal Hypertension, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 3 inclusion and 5 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 21 Mar 2007. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compared efficacy (at least 6 moths of follow-up). 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 21 Mar 2007.