Study Stopped
The sponsor decided to continue with a different design and a different protocol.
Cardiac Safety of Lansoprazole and Domperidon Combination
Cardiac Safety Evaluation of Lansoprazole/Domperidone 30/30 mg Sustained Release Capsule Formulation
1 other identifier
interventional
N/A
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2018
Shorter than P25 for phase_4
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2017
CompletedFirst Posted
Study publicly available on registry
November 28, 2017
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedJanuary 5, 2023
January 1, 2023
9 months
November 20, 2017
January 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in QT and corrected QT (QTc) interval compared to baseline
8 weeks
Secondary Outcomes (1)
Change in upper gastrointestinal symptom severity index compared to baseline.
8 weeks
Study Arms (2)
Lansoprazole/Domperidone
EXPERIMENTALPatient 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
ACTIVE COMPARATORPatient will be administered lansoprazole 30 mg capsules (brand name: Lasotab) half an hour before breakfast for eight weeks according to randomisation scheme.
Interventions
Experimental
Eligibility Criteria
You may qualify if:
- GERD patients with BMI 18-33 kg/m2
- Patients with esophagitis class A-B according to Los Angeles classification
You may not qualify if:
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
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)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Serhat Bor, Prof Dr
Ege University Medical Faculty Gastroenterology Dep.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2017
First Posted
November 28, 2017
Study Start
March 1, 2018
Primary Completion
December 1, 2018
Study Completion
January 1, 2019
Last Updated
January 5, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share