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Cardiac Safety of Lansoprazole and Domperidon Combination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355170
Recruitment Status : Unknown
Verified December 2017 by Neutec Ar-Ge San ve Tic A.Ş.
Recruitment status was:  Not yet recruiting
First Posted : November 28, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Neutec Ar-Ge San ve Tic A.Ş

Study Description
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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
GERD Cardiac Event Safety Issues Combination Product: Lansoprazole/Domperidone Drug: Lansoprazole Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Cardiac Safety Evaluation of Lansoprazole/Domperidone 30/30 mg Sustained Release Capsule Formulation
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
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 Name: Duolans
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 Name: Lasotab


Outcome Measures
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Primary Outcome Measures :
  1. Change in QT and corrected QT (QTc) interval compared to baseline [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change in upper gastrointestinal symptom severity index compared to baseline. [ Time Frame: 8 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355170


Contacts
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Contact: Neutec R&D 00902128505102 ext 0000 iremkaraman@neutecrdc.com

Locations
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Turkey
Başkent University Hospital Gastroenterology Dep.
Adana, Turkey
Contact: Birol Özer, Prof Dr       birolozer@yahoo.com   
Çukurova University Medical Faculty Cardiology Dep.
Adana, Turkey
Contact: Mesut Demir, Prof Dr       mdemir46@hotmail.com   
Ankara University Medical Faculty Gastroenterology Dep.
Ankara, Turkey
Contact: Mehmet Bektaş, Prof Dr       Mehmet.Bektas@medicine.ankara.edu.tr   
Dışkapı Research and Training Hospital Gastroenterology Dep.
Ankara, Turkey
Contact: Elife Erarslan, Assoc Prof Dr       elifeerarslan@gmail.com   
Yüksek İhtisas Research and Training Hospital Gastroenterology Dep.
Ankara, Turkey
Contact: İsmail Hakkı Kalkan, Assoc Prof Dr       drismailster@gmail.com   
Antalya Research and Training Hospital Gastroenterology Dep.
Antalya, Turkey
Contact: Ayhan Hilmi Çekin, Assoc Prof Dr       ayhancekin@hotmail.com   
Balıkesir University Medical Faculty Gastroenterology Dep.
Balıkesir, Turkey
Contact: Ayla Yıldız Savaş       drmssa@gmail.com   
Gaziantep Şahinbey Research and Training Hospital Gastroenterology Dep.
Gaziantep, Turkey
Contact: Abdullah Emre Yıldırım, Assoc Prof Dr       draemreyildirim@gmail.com   
Dr. Sadi Konuk Research and Training Hospital Gastroenterology Dep.
Istanbul, Turkey
Contact: Aliye Soylu, Prof Dr       aliyesoylu@superonline.com   
Ümraniye Research and Training Hospital Gastroenterology Dep.
Istanbul, Turkey
Contact: Zuhal Çalışkan, Assoc Prof Dr       caliskanzuhal@gmail.com   
Ege University Medical Faculty Gastroenterology Dep.
İzmir, Turkey
Contact: Serhat Bor, Prof Dr       serhatbor@yahoo.com   
Tepecik Research and Training Hospital Gastroenterology Dep.
İzmir, Turkey
Contact: Betül Paköz, MD       betulpakoz@yahoo.com   
Celal Bayar University Medical Faculty Gastroenterology Dep.
Manisa, Turkey
Contact: Elmas Kasap, Assoc Prof Dr       elmaskasap@yahoo.com   
Sıtkı Koçman University Medical Faculty Gastroenterology Dep.
Muğla, Turkey
Contact: Burak Özşeker, Assoc Prof Dr       burakozseker@gmail.com   
Recep Tayyip Erdoğan University Medical Faculty Gastroenterology Dep.
Rize, Turkey
Contact: Remzi Adnan Akdoğan, Assoc Prof Dr       remziadnan@yahoo.com   
Cumhuriyet University Medical Faculty Gastroenterology Dep.
Sivas, Turkey
Contact: Özlem Yönem, Prof Dr       ozlemyonem@gmail.com   
Sponsors and Collaborators
Neutec Ar-Ge San ve Tic A.Ş
Investigators
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Study Chair: Serhat Bor, Prof Dr Ege University Medical Faculty Gastroenterology Dep.
More Information
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Responsible Party: Neutec Ar-Ge San ve Tic A.Ş
ClinicalTrials.gov Identifier: NCT03355170    
Other Study ID Numbers: NEU-05.16
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Domperidone
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents