Cardiac Safety of Lansoprazole and Domperidon Combination
NCT ID: NCT03355170
Last Updated: 2023-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2018-03-01
2019-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
TRIPLE
Study Groups
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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/Domperidone
Experimental
Lansoprazole
Patient will be administered lansoprazole 30 mg capsules (brand name: Lasotab) half an hour before breakfast for eight weeks according to randomisation scheme.
Lansoprazole
Active comparator
Interventions
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Lansoprazole/Domperidone
Experimental
Lansoprazole
Active comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with esophagitis class A-B according to Los Angeles classification
Exclusion Criteria
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Neutec Ar-Ge San ve Tic A.Ş
INDUSTRY
Responsible Party
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Principal Investigators
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Serhat Bor, Prof Dr
Role: STUDY_CHAIR
Ege University Medical Faculty Gastroenterology Dep.
Locations
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Başkent University Hospital Gastroenterology Dep.
Adana, , Turkey (Türkiye)
Çukurova University Medical Faculty Cardiology Dep.
Adana, , Turkey (Türkiye)
Ankara University Medical Faculty Gastroenterology Dep.
Ankara, , Turkey (Türkiye)
Dışkapı Research and Training Hospital Gastroenterology Dep.
Ankara, , Turkey (Türkiye)
Yüksek İhtisas Research and Training Hospital Gastroenterology Dep.
Ankara, , Turkey (Türkiye)
Antalya Research and Training Hospital Gastroenterology Dep.
Antalya, , Turkey (Türkiye)
Balıkesir University Medical Faculty Gastroenterology Dep.
Balıkesir, , Turkey (Türkiye)
Gaziantep Şahinbey Research and Training Hospital Gastroenterology Dep.
Gaziantep, , Turkey (Türkiye)
Dr. Sadi Konuk Research and Training Hospital Gastroenterology Dep.
Istanbul, , Turkey (Türkiye)
Ümraniye Research and Training Hospital Gastroenterology Dep.
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty Gastroenterology Dep.
Izmir, , Turkey (Türkiye)
Tepecik Research and Training Hospital Gastroenterology Dep.
Izmir, , Turkey (Türkiye)
Celal Bayar University Medical Faculty Gastroenterology Dep.
Manisa, , Turkey (Türkiye)
Sıtkı Koçman University Medical Faculty Gastroenterology Dep.
Muğla, , Turkey (Türkiye)
Recep Tayyip Erdoğan University Medical Faculty Gastroenterology Dep.
Rize, , Turkey (Türkiye)
Cumhuriyet University Medical Faculty Gastroenterology Dep.
Sivas, , Turkey (Türkiye)
Countries
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Other Identifiers
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NEU-05.16
Identifier Type: -
Identifier Source: org_study_id
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