Cardiac Safety of Lansoprazole and Domperidon Combination

Study Overview
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Brief Summary
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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.

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

Conditions
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GERD, Cardiac Event, Safety Issues

Intervention / Treatment
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* Combination Product: Lansoprazole/Domperidone
* Drug: Lansoprazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lansoprazole/Domperidone<br>Patient will be administered lansoprazole/domperidone 30/30 mg capsules (brand name: Duolans) half an hour before breakfast for eight weeks according to randomisation scheme. | Combination Product: Lansoprazole/Domperidone<br>* Experimental<br>* Other names: Duolans;|
| Active Comparator: Lansoprazole<br>Patient will be administered lansoprazole 30 mg capsules (brand name: Lasotab) half an hour before breakfast for eight weeks according to randomisation scheme. | Drug: Lansoprazole<br>* Active comparator<br>* Other names: Lasotab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in QT and corrected QT (QTc) interval compared to baseline |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in upper gastrointestinal symptom severity index compared to baseline. |  | 8 weeks |