Cardiac Safety of Lansoprazole and Domperidon Combination

January 4, 2023 updated by: Neutec Ar-Ge San ve Tic A.Ş

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in QT and corrected QT (QTc) interval compared to baseline
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in upper gastrointestinal symptom severity index compared to baseline.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neutec Ar-Ge San ve Tic A.Ş

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Serhat Bor, Prof Dr, Ege University Medical Faculty Gastroenterology Dep.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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