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Status:

WITHDRAWN

Cardiac Safety of Lansoprazole and Domperidon Combination

Lead Sponsor:

Neutec Ar-Ge San ve Tic A.Ş

Conditions:

GERD

Cardiac Event

Eligibility:

All Genders

18-60 years

Phase:

PHASE4

Brief Summary

The aim of current study is to compare safety and efficacy of lansoprazole/domperidone 30/30 mg sustained release capsules (brand name: Duolans) and lansoprazole 30 mg micropellet capsules (brand name...

Eligibility Criteria

Inclusion

  • GERD patients with BMI 18-33 kg/m2
  • Patients with esophagitis class A-B according to Los Angeles classification

Exclusion

  • Patients whose long QT syndrome risk score \> 3.
  • Patients with family history of short or long QT syndrome.
  • Patients with Barrett's stricture, gastric outlet obstruction, malignancy, gastrointestinal system bleeding or any other upper gastrointestinal system pathology.
  • Patients whose Hiatus hernia is \> 3 cm.
  • Patients with uncontrolled or insulin dependent diabetes mellitus, symptomatic gallbladder stone, active or unhealed stomach or duodenum ulcer, Zollinger-Ellison syndrome, primary esophagus motility disorder, pancreatitis, inflammatory bowel disease, severe lung disease, chronic liver disease, uncontrolled kidney impairment, cancer (except skin cancer except melanoma), cerebrovascular disease, epilepsy.
  • Patients with history of heart failure, ventricular tachycardia, ventricular fibrillation, cardiac arrest, Torsades de pointes, bradycardia, sinus node dysfunction, heart attack, long QTc (\>460 ms).
  • Patients taken PPIs or H2-blockers within 7 days and prokinetic drugs within 3 days before entering the study.
  • Patients with major psychiatric disease.
  • Alcoholism and drug use.
  • Patients with pathologic laboratory tests; hemogram, sedimentation, CRP, thyroid functions tests, liver enzymes.
  • Malabsorption.
  • Immunosuppressive patients.
  • Patients taken cortisone.
  • Patients taken other drugs that prolong QT interval.
  • Patients taken drugs that need gastric acid for optimal absorption; ketoconazole, iron salts, digoxin, ampicillin esters, anticoagulants, antineoplastic agents, prostaglandin analogues, sucralfate, atazanavir, theophylline, tacrolimus, fluvoxamine, rifampisin, nefazodone and aprepitant.
  • Patients taken drugs carried with P-glycoprotein, indicated for heart diseases, AIDS/HIV or infection treatment.
  • Pregnancy or breast-feeding.
  • Patients taken drugs that may affect gastrointestinal system motility or acid release.
  • History of abdominal surgery (hysterectomy, abdominal hernia repair, caesarean cases may be included; cholecystectomy have to be excluded).
  • Patients with hypocalcemia and hypercalcemia
  • Patients taken NSAII drugs (paracetamol may be used up to 2 gr/day).
  • Patients taken antidepressants.
  • Hypersensitivity to study drugs.

Key Trial Info

Start Date :

March 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2019

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT03355170

Start Date

March 1 2018

End Date

January 1 2019

Last Update

January 5 2023

Active Locations (16)

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Page 1 of 4 (16 locations)

1

Başkent University Hospital Gastroenterology Dep.

Adana, Turkey (Türkiye)

2

Çukurova University Medical Faculty Cardiology Dep.

Adana, Turkey (Türkiye)

3

Ankara University Medical Faculty Gastroenterology Dep.

Ankara, Turkey (Türkiye)

4

Dışkapı Research and Training Hospital Gastroenterology Dep.

Ankara, Turkey (Türkiye)