Liver CirrhosisPhase 2/3PUNCT04140591
Proton Pump Inhibitor Plus Propranolol Versus Proton Pump Inhibitor Alone on Peptic Ulcer Healing in Patients With Liver Cirrhosis
A Phase 2/3 study testing Proton-pump inhibitor and Propranolol+Proton-pump inhibitor in people with Liver Cirrhosis and Peptic Ulcer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Proton pump inhibitor plus propranolol versus proton pump inhibitor alone on peptic ulcer healing in patients with liver cirrhosis: a randomized trail Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Liver Cirrhosis, Peptic Ulcer
- What is being tested?
- Proton-pump inhibitor and Propranolol+Proton-pump inhibitor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Dec 2016to 31 Dec 2019
- Phase
- Phase 2/3
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 20 and 85 years old
- Liver cirrhosis associated with esophageal varices or gastric varices
- Gastric ulcer or duodenal ulcer ,size bigger or egual than 0.5 cm
Who cannot join
- Acute bleeding
- Steroid or NSAID user
- Pregnancy, or the patients with other terminal illness (such as other terminal cancers, heart failure, renal failure...)
- Propranolol contraindications (such as atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, severe peripheral arterial disease...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proton Pump Inhibitor Plus Propranolol Versus Proton Pump Inhibitor Alone on Peptic Ulcer Healing in Patients With Liver Cirrhosis: a Randomized Trail
Proton pump inhibitor plus propranolol versus proton pump inhibitor alone on peptic ulcer healing in patients with liver cirrhosis: a randomized trail
Read the detailed description
Portal hypertension is responsible for the development of portosystemic collaterals. The hemodynamic alternations may result in mucosal and vascular changes along gastrointestinal (GI) tract as well. According to several epidemiological studies, cirrhotic patients are at a higher risk of developing peptic ulcers, delayed healing, and a higher frequency of ulcer recurrence. The death rate from peptic ulcer disease in cirrhotic patients has been reported to be five times higher than that of the general population. The exact mechanism remains incompletely understood, but may be related to impaired mucosal defense mechanisms. Aggressive factors such as Helicobacter pylori and gastric acid may not be the predominant etiology in such circumstances. Sarfeh et al. found gastric mucosa of portal hypertensive rats, compared with that of controls, has distinctive functional and histologic abnormalities that can explain its increased susceptibility to erosive injury. Auroux et al. found gastroduodenal ulcer was independently associated only with the severity of the hypertensive gastropathy in cirrhotics. Chen et al. found portal hypertension with a hepatic venous pressure gradient > 12 mmHg may be an important factor contributing to the increased prevalence of gastric ulcer observed in patients with liver cirrhosis. Thereby, we presumed that clinically significant portal hypertension may play a role in development of peptic ulcer in cirrhotic patients. Lebrec et al. elucidated non-selective beta-blocker (NSBB) could significantly decrease portal pressure and lower the risk of GI bleeding in patients with cirrhosis. Kitano et al. found portal hypotensive treatment with NSBB, reduces ethanol-induced gastric mucosal damage in portal hypertensive rats and improves endoscopic signs of portal hypertensive gastropathy in cirrhosis patients. We designed a 2-year randomized trial to evaluate the effectiveness of proton pump inhibitor with or without propranolol on ulcer healing and the incidence of ulcer bleeding in patients with cirrhosis and peptic ulcers.
- Conditions
- Liver Cirrhosis, Peptic Ulcer
- Being tested
- Proton-pump inhibitor, Propranolol+Proton-pump inhibitor
- Keywords
- Portal hypertension, Peptic ulcer, Non-selective beta-blocker, Proton pump inhibitor
- Medical subject headings
- Liver Cirrhosis, Peptic Ulcer, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton-pump inhibitorDrug
Also called Pariet EC, PPI
PPI: Pariet EC 20mg/QDAC
Propranolol+Proton-pump inhibitorDrug
Also called Inderal, Cardolol
Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate>55 or systemic blood pressure >90mmHg) PPI: Pariet EC 20mg/QDAC
| Study group | Role | What they receive |
|---|---|---|
| Proton-pump inhibitor | Placebo comparator | PPI: Pariet EC 20 mg/QDAC Receives: Drug: Proton-pump inhibitor |
| Propranolol+Proton-pump inhibitor | Active comparator | Propranolol:
Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate>55 or systemic blood pressure>90mmHg)
PPI: Pariet EC 20 mg/QDAC Receives: Drug: Propranolol+Proton-pump inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of peptic ulcer
if propranolol can help cure peptic ulcer
Measured: 2 months
Bleeding rate of peptic ulcer
if propranolol can help decrease the rate of ulcer bleeding
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start26 Dec 2016
- Primary completion31 Oct 2019
- Study completion31 Dec 2019
Why it stopped: 1\. Most patients with liver cirrhosis already use PPI and NSBB 2. 90 % Peptic ulcer size is smaller than 5cm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Ming-Chih mchou@vghtpe.gov.tw, MD, Principal investigator, Institutional Review Board, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140591
- Sponsor's protocol ID
- V106C-137
- Acronym
- PU
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2019
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Pump Inhibitor Plus Propranolol Versus Proton Pump Inhibitor Alone on Peptic Ulcer Healing in Patients With Liver Cirrhosis: a Randomized Trail
- ClinicalTrials.gov ID
- NCT04140591
- Acronym / sponsor ID
- PU / V106C-137
- Conditions
- Liver Cirrhosis, Peptic Ulcer
- Keywords
- Portal hypertension, Peptic ulcer, Non-selective beta-blocker, Proton pump inhibitor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 1\. Most patients with liver cirrhosis already use PPI and NSBB 2. 90 % Peptic ulcer size is smaller than 5cm
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 26 Dec 2016 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Oct 2019 (actual)
- 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.
Proton pump inhibitor plus propranolol versus proton pump inhibitor alone on peptic ulcer healing in patients with liver cirrhosis: a randomized trail
Detailed description
Portal hypertension is responsible for the development of portosystemic collaterals. The hemodynamic alternations may result in mucosal and vascular changes along gastrointestinal (GI) tract as well. According to several epidemiological studies, cirrhotic patients are at a higher risk of developing peptic ulcers, delayed healing, and a higher frequency of ulcer recurrence. The death rate from peptic ulcer disease in cirrhotic patients has been reported to be five times higher than that of the general population. The exact mechanism remains incompletely understood, but may be related to impaired mucosal defense mechanisms. Aggressive factors such as Helicobacter pylori and gastric acid may not be the predominant etiology in such circumstances. Sarfeh et al. found gastric mucosa of portal hypertensive rats, compared with that of controls, has distinctive functional and histologic abnormalities that can explain its increased susceptibility to erosive injury. Auroux et al. found gastroduodenal ulcer was independently associated only with the severity of the hypertensive gastropathy in cirrhotics. Chen et al. found portal hypertension with a hepatic venous pressure gradient > 12 mmHg may be an important factor contributing to the increased prevalence of gastric ulcer observed in patients with liver cirrhosis. Thereby, we presumed that clinically significant portal hypertension may play a role in development of peptic ulcer in cirrhotic patients. Lebrec et al. elucidated non-selective beta-blocker (NSBB) could significantly decrease portal pressure and lower the risk of GI bleeding in patients with cirrhosis. Kitano et al. found portal hypotensive treatment with NSBB, reduces ethanol-induced gastric mucosal damage in portal hypertensive rats and improves endoscopic signs of portal hypertensive gastropathy in cirrhosis patients. We designed a 2-year randomized trial to evaluate the effectiveness of proton pump inhibitor with or without propranolol on ulcer healing and the incidence of ulcer bleeding in patients with cirrhosis and peptic ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proton-pump inhibitor | Placebo comparator | Drug: Proton-pump inhibitorPPI: Pariet EC 20 mg/QDAC |
| Propranolol+Proton-pump inhibitor | Active comparator | Drug: Propranolol+Proton-pump inhibitorPropranolol: Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate>55 or systemic blood pressure>90mmHg) PPI: Pariet EC 20 mg/QDAC |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between 20 and 85 years old
- Liver cirrhosis associated with esophageal varices or gastric varices
- Gastric ulcer or duodenal ulcer ,size bigger or egual than 0.5 cm
Key exclusion criteria (4 listed)
- Acute bleeding
- Steroid or NSAID user
- Pregnancy, or the patients with other terminal illness (such as other terminal cancers, heart failure, renal failure...)
- Propranolol contraindications (such as atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, severe peripheral arterial disease...)
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 |
|---|---|---|
| Proton-pump inhibitorAlso: Pariet EC, PPIPPI: Pariet EC 20mg/QDAC | Drug | Proton-pump inhibitor |
| Propranolol+Proton-pump inhibitorAlso: Inderal, CardololPropranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate>55 or systemic blood pressure >90mmHg) PPI: Pariet EC 20mg/QDAC | Drug | Propranolol+Proton-pump inhibitor |
Primary outcome
Healing of peptic ulcer
Time frame: 2 months
if propranolol can help cure peptic ulcer
Bleeding rate of peptic ulcer
Time frame: 2 months
if propranolol can help decrease the rate of ulcer bleeding
Results and safety
The study was stopped early (reason given: 1\. Most patients with liver cirrhosis already use PPI and NSBB 2. 90 % Peptic ulcer size is smaller than 5cm). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
Ming-Chih mchou@vghtpe.gov.tw, MD principal investigator
Institutional Review Board, Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Proton-pump inhibitor and Propranolol+Proton-pump inhibitor in people with Liver Cirrhosis and Peptic Ulcer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 4 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: stopped early, as of the sponsor's last update on 23 Jun 2020. 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: 1\. Most patients with liver cirrhosis already use PPI and NSBB 2. 90 % Peptic ulcer size is smaller than 5cm). Results are not available in the source record.
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?
Healing of peptic ulcer (time frame: 2 months). The study lists 2 primary outcomes in all. 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 23 Jun 2020.