Clinical trial NCT03355170: Cardiac Safety of Lansoprazole and Domperidon Combination
Official title: Cardiac Safety Evaluation of Lansoprazole/Domperidone 30/30 mg Sustained Release Capsule Formulation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: GERD
Cardiac Event
Safety Issues
Lead sponsor: Neutec Ar-Ge San ve Tic A.Ş
Sponsor class: INDUSTRY
First posted: 2017-11-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility 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.

Primary outcomes:
measure: Change in QT and corrected QT (QTc) interval compared to baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in upper gastrointestinal symptom severity index compared to baseline.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Başkent University Hospital Gastroenterology Dep.
city: Adana
country: Turkey
facility: Çukurova University Medical Faculty Cardiology Dep.
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty Gastroenterology Dep.
city: Ankara
country: Turkey
facility: Dışkapı Research and Training Hospital Gastroenterology Dep.
city: Ankara
country: Turkey
facility: Yüksek İhtisas Research and Training Hospital Gastroenterology Dep.
city: Antalya
country: Turkey
facility: Antalya Research and Training Hospital Gastroenterology Dep.
city: Balıkesir
country: Turkey
facility: Balıkesir University Medical Faculty Gastroenterology Dep.
city: Gaziantep
country: Turkey
facility: Gaziantep Şahinbey Research and Training Hospital Gastroenterology Dep.
city: Istanbul
country: Turkey
facility: Dr. Sadi Konuk Research and Training Hospital Gastroenterology Dep.
city: Istanbul
country: Turkey
facility: Ümraniye Research and Training Hospital Gastroenterology Dep.
city: İzmir
country: Turkey
facility: Ege University Medical Faculty Gastroenterology Dep.
city: İzmir
country: Turkey
facility: Tepecik Research and Training Hospital Gastroenterology Dep.
city: Manisa
country: Turkey
facility: Celal Bayar University Medical Faculty Gastroenterology Dep.
city: Muğla
country: Turkey
facility: Sıtkı Koçman University Medical Faculty Gastroenterology Dep.
city: Rize
country: Turkey
facility: Recep Tayyip Erdoğan University Medical Faculty Gastroenterology Dep.
city: Sivas
country: Turkey
facility: Cumhuriyet University Medical Faculty Gastroenterology Dep.
Study officials:
affiliation: Ege University Medical Faculty Gastroenterology Dep.
name: Serhat Bor, Prof Dr
role: STUDY_CHAIR
References: