Cardiac Safety of Lansoprazole and Domperidon Combination

Phase 4

Withdrawn

• Conditions: GERD; Cardiac Event; Safety Issues
• Interventions: Combination Product: Lansoprazole/Domperidone; Drug: Lansoprazole

• Registration Number: NCT03355170
• Lead Sponsor: Neutec Ar-Ge San ve Tic A.Ş

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-27
• Study First Posted: 2017-11-28
• Study Start: 2018-03-01
• Primary Completion: 2018-12-01
• Study Completion: 2019-01-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in QT and corrected QT (QTc) interval compared to baseline	8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in upper gastrointestinal symptom severity index compared to baseline.	8 weeks

Trial Locations

Locations (16)

Dr. Sadi Konuk Research and Training Hospital Gastroenterology Dep.; 🇹🇷 Istanbul, Turkey

Tepecik Research and Training Hospital Gastroenterology Dep.; 🇹🇷 İzmir, Turkey

Cumhuriyet University Medical Faculty Gastroenterology Dep.; 🇹🇷 Sivas, Turkey

Balıkesir University Medical Faculty Gastroenterology Dep.; 🇹🇷 Balıkesir, Turkey

Gaziantep Şahinbey Research and Training Hospital Gastroenterology Dep.; 🇹🇷 Gaziantep, Turkey

Ümraniye Research and Training Hospital Gastroenterology Dep.; 🇹🇷 Istanbul, Turkey

Recep Tayyip Erdoğan University Medical Faculty Gastroenterology Dep.; 🇹🇷 Rize, Turkey

Antalya Research and Training Hospital Gastroenterology Dep.; 🇹🇷 Antalya, Turkey

Başkent University Hospital Gastroenterology Dep.; 🇹🇷 Adana, Turkey

Çukurova University Medical Faculty Cardiology Dep.; 🇹🇷 Adana, Turkey

Yüksek İhtisas Research and Training Hospital Gastroenterology Dep.; 🇹🇷 Ankara, Turkey

Ankara University Medical Faculty Gastroenterology Dep.; 🇹🇷 Ankara, Turkey

Dışkapı Research and Training Hospital Gastroenterology Dep.; 🇹🇷 Ankara, Turkey

Ege University Medical Faculty Gastroenterology Dep.; 🇹🇷 İzmir, Turkey

Sıtkı Koçman University Medical Faculty Gastroenterology Dep.; 🇹🇷 Muğla, Turkey

Celal Bayar University Medical Faculty Gastroenterology Dep.; 🇹🇷 Manisa, Turkey