Cardiac Event, GERD, Safety Issues
Conditions
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: Lasotab) in GERD patients in terms of cardiac safety.
Interventions
COMBINATION_PRODUCTLansoprazole/Domperidone
Experimental
DRUGLansoprazole
Active comparator
Sponsors
Neutec Ar-Ge San ve Tic A.Ş
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in QT and corrected QT (QTc) interval compared to baseline | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in upper gastrointestinal symptom severity index compared to baseline. | 8 weeks |
Countries
Turkey (Türkiye)
Outcome results
None listed