Proton Pump Inhibitor Plus Propranolol Versus Proton Pump Inhibitor Alone on Peptic Ulcer Healing in Patients With Liver Cirrhosis

NCT04140591 | Terminated Phase 2

• 1 other identifier: V106C-137
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Proton pump inhibitor plus propranolol versus proton pump inhibitor alone on peptic ulcer healing in patients with liver cirrhosis: a randomized trail

Conditions

Liver Cirrhosis; Peptic Ulcer

Keywords

Portal hypertension; Peptic ulcer; Non-selective beta-blocker; Proton pump inhibitor

Outcome Measures

Primary Outcomes (2)

• Healing of peptic ulcer

  if propranolol can help cure peptic ulcer

  2 months

• Bleeding rate of peptic ulcer

  if propranolol can help decrease the rate of ulcer bleeding

  2 months

Study Arms (2)

Proton-pump inhibitor

PLACEBO COMPARATOR

PPI: Pariet EC 20 mg/QDAC

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

Drug: Propranolol+Proton-pump inhibitor

Interventions

Proton-pump inhibitor DRUG

PPI: Pariet EC 20mg/QDAC

Also known as: Pariet EC, PPI

Proton-pump inhibitor

Propranolol+Proton-pump inhibitor DRUG

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

Also known as: Inderal, Cardolol

Propranolol+Proton-pump inhibitor

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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...)

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital, Taiwan

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Liver Cirrhosis; Peptic Ulcer; Hypertension, Portal

Interventions

Proton Pump Inhibitors; Propranolol

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Ming-Chih mchou@vghtpe.gov.tw, MD

  Institutional Review Board, Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Division of Gastroenterology & Hepatology

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: October 28, 2019
• Study Start: December 26, 2016
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 23, 2020

Record last verified: 2019-09

Locations

TW (1)