Cardiac Safety of Lansoprazole and Domperidon Combination

Sponsor
Neutec Ar-Ge San ve Tic A.Ş (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03355170
Collaborator
(none)
100
16
2
10.1
6.3
0.6

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
Phase 4

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Jan 1, 2019

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in QT and corrected QT (QTc) interval compared to baseline [8 weeks]

    Secondary Outcome Measures

    1. Change in upper gastrointestinal symptom severity index compared to baseline. [8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Neutec Ar-Ge San ve Tic A.Ş
    ClinicalTrials.gov Identifier:
    NCT03355170
    Other Study ID Numbers:
    • NEU-05.16
    First Posted:
    Nov 28, 2017
    Last Update Posted:
    Dec 13, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 13, 2017