Cardiac Safety Evaluation of Lansoprazole/Domperidone 30/30 mg Sustained Release Capsule Formulation

NEU-05.16

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: Lasotab) in GERD patients in terms of cardiac safety.

2018-03-01

2018-12-01

2019-01-01

Withdrawn

Early phase I

Inclusion Criteria: * GERD patients with BMI 18-33 kg/m2 * Patients with esophagitis class A-B according to Los Angeles classification Exclusion Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-01-05