Cardiac Safety of Lansoprazole and Domperidon Combination

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neutec Ar-Ge San ve Tic A.Ş
• Treatments: Dexlansoprazole; Domperidone; Lansoprazole

Criteria

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.