Cardiac Safety of Lansoprazole and Domperidon Combination

Cardiac Safety Evaluation of Lansoprazole/Domperidone 30/30 mg Sustained Release Capsule Formulation

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.

Study Overview

• Status: Withdrawn
• Conditions: GERD; Cardiac Event; Safety Issues
• Intervention / Treatment: Combination product: Lansoprazole/Domperidone; Drug: Lansoprazole

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey
    • Başkent University Hospital Gastroenterology Dep.
  • Adana, Turkey
    • Çukurova University Medical Faculty Cardiology Dep.
  • Ankara, Turkey
    • Ankara University Medical Faculty Gastroenterology Dep.
  • Ankara, Turkey
    • Dışkapı Research and Training Hospital Gastroenterology Dep.
  • Ankara, Turkey
    • Yüksek İhtisas Research and Training Hospital Gastroenterology Dep.
  • Antalya, Turkey
    • Antalya Research and Training Hospital Gastroenterology Dep.
  • Balıkesir, Turkey
    • Balıkesir University Medical Faculty Gastroenterology Dep.
  • Gaziantep, Turkey
    • Gaziantep Şahinbey Research and Training Hospital Gastroenterology Dep.
  • Istanbul, Turkey
    • Dr. Sadi Konuk Research and Training Hospital Gastroenterology Dep.
  • Istanbul, Turkey
    • Ümraniye Research and Training Hospital Gastroenterology Dep.
  • Manisa, Turkey
    • Celal Bayar University Medical Faculty Gastroenterology Dep.
  • Muğla, Turkey
    • Sıtkı Koçman University Medical Faculty Gastroenterology Dep.
  • Rize, Turkey
    • Recep Tayyip Erdoğan University Medical Faculty Gastroenterology Dep.
  • Sivas, Turkey
    • Cumhuriyet University Medical Faculty Gastroenterology Dep.
  • İzmir, Turkey
    • Ege University Medical Faculty Gastroenterology Dep.
  • İzmir, Turkey
    • Tepecik Research and Training Hospital Gastroenterology Dep.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Lasotab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in QT and corrected QT (QTc) interval compared to baseline	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in upper gastrointestinal symptom severity index compared to baseline.	8 weeks

Collaborators and Investigators

• Sponsor: Neutec Ar-Ge San ve Tic A.Ş
• Investigators: Study Chair: Serhat Bor, Prof Dr, Ege University Medical Faculty Gastroenterology Dep.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine Antagonists; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole; Domperidone
• Other Study ID Numbers: NEU-05.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No