Cardiac Safety of Lansoprazole and Domperidon Combination
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 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. |
Combination Product: Lansoprazole/Domperidone
Experimental
Other Names:
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Active Comparator: Lansoprazole Patient will be administered lansoprazole 30 mg capsules (brand name: Lasotab) half an hour before breakfast for eight weeks according to randomisation scheme. |
Drug: Lansoprazole
Active comparator
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change in QT and corrected QT (QTc) interval compared to baseline [8 weeks]
Secondary Outcome Measures
- Change in upper gastrointestinal symptom severity index compared to baseline. [8 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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GERD patients with BMI 18-33 kg/m2
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Patients with esophagitis class A-B according to Los Angeles classification
Exclusion Criteria:
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Patients whose long QT syndrome risk score > 3.
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Patients with family history of short or long QT syndrome.
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Patients with Barrett's stricture, gastric outlet obstruction, malignancy, gastrointestinal system bleeding or any other upper gastrointestinal system pathology.
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Patients whose Hiatus hernia is > 3 cm.
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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.
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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).
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Patients taken PPIs or H2-blockers within 7 days and prokinetic drugs within 3 days before entering the study.
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Patients with major psychiatric disease.
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Alcoholism and drug use.
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Patients with pathologic laboratory tests; hemogram, sedimentation, CRP, thyroid functions tests, liver enzymes.
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Malabsorption.
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Immunosuppressive patients.
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Patients taken cortisone.
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Patients taken other drugs that prolong QT interval.
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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.
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Patients taken drugs carried with P-glycoprotein, indicated for heart diseases, AIDS/HIV or infection treatment.
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Pregnancy or breast-feeding.
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Patients taken drugs that may affect gastrointestinal system motility or acid release.
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History of abdominal surgery (hysterectomy, abdominal hernia repair, caesarean cases may be included; cholecystectomy have to be excluded).
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Patients with hypocalcemia and hypercalcemia
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Patients taken NSAII drugs (paracetamol may be used up to 2 gr/day).
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Patients taken antidepressants.
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Hypersensitivity to study drugs.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Başkent University Hospital Gastroenterology Dep. | Adana | Turkey | ||
2 | Çukurova University Medical Faculty Cardiology Dep. | Adana | Turkey | ||
3 | Ankara University Medical Faculty Gastroenterology Dep. | Ankara | Turkey | ||
4 | Dışkapı Research and Training Hospital Gastroenterology Dep. | Ankara | Turkey | ||
5 | Yüksek İhtisas Research and Training Hospital Gastroenterology Dep. | Ankara | Turkey | ||
6 | Antalya Research and Training Hospital Gastroenterology Dep. | Antalya | Turkey | ||
7 | Balıkesir University Medical Faculty Gastroenterology Dep. | Balıkesir | Turkey | ||
8 | Gaziantep Şahinbey Research and Training Hospital Gastroenterology Dep. | Gaziantep | Turkey | ||
9 | Dr. Sadi Konuk Research and Training Hospital Gastroenterology Dep. | Istanbul | Turkey | ||
10 | Ümraniye Research and Training Hospital Gastroenterology Dep. | Istanbul | Turkey | ||
11 | Ege University Medical Faculty Gastroenterology Dep. | İzmir | Turkey | ||
12 | Tepecik Research and Training Hospital Gastroenterology Dep. | İzmir | Turkey | ||
13 | Celal Bayar University Medical Faculty Gastroenterology Dep. | Manisa | Turkey | ||
14 | Sıtkı Koçman University Medical Faculty Gastroenterology Dep. | Muğla | Turkey | ||
15 | Recep Tayyip Erdoğan University Medical Faculty Gastroenterology Dep. | Rize | Turkey | ||
16 | Cumhuriyet University Medical Faculty Gastroenterology Dep. | Sivas | Turkey |
Sponsors and Collaborators
- Neutec Ar-Ge San ve Tic A.Ş
Investigators
- Study Chair: Serhat Bor, Prof Dr, Ege University Medical Faculty Gastroenterology Dep.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NEU-05.16