Cardiac Safety of Lansoprazole and Domperidon Combination (NCT03355170) | Clinical Trial Compass
WithdrawnPhase 4
Cardiac Safety of Lansoprazole and Domperidon Combination
Stopped: The sponsor decided to continue with a different design and a different protocol.
Turkey (Türkiye)0Started 2018-03-01
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 prolo…
What they're measuring
1
Change in QT and corrected QT (QTc) interval compared to baseline