Cardiac Safety of Lansoprazole and Domperidon Combination

Neutec Ar-Ge San ve Tic

Status and phase: Withdrawn; Phase 4

Conditions: Safety Issues; GERD; Cardiac Event

Treatments: Combination Product: Lansoprazole/Domperidone; Drug: Lansoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03355170

NEU-05.16

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Lansoprazole/Domperidone

Experimental group

Description:

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.

Treatment:

Combination Product: Lansoprazole/Domperidone

Lansoprazole

Active Comparator group

Description:

Patient will be administered lansoprazole 30 mg capsules (brand name: Lasotab) half an hour before breakfast for eight weeks according to randomisation scheme.

Treatment:

Drug: Lansoprazole