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WithdrawnNCT03355170Updated Jan 5, 2023

Cardiac Safety of Lansoprazole and Domperidon Combination

A Phase 4 interventional study of Lansoprazole/Domperidone and Lansoprazole in GERD, Cardiac Event and Safety Issues, sponsored by Neutec Ar-Ge San ve Tic A.Ş. Withdrawn at 16 sites in Turkey. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-01-05.

Sponsored by Neutec Ar-Ge San ve Tic A.Ş · Phase 4, Interventional, and Screening

Why this study was withdrawn
The sponsor decided to continue with a different design and a different protocol.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • GERD
  • Cardiac Event
  • Safety Issues
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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.
04

Study design

Phase
Phase 4
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Combination productLansoprazole/Domperidone

    Experimental

    Also known as: Duolans

  • DrugLansoprazole

    Active comparator

    Also known as: Lasotab

05

What researchers measure

Primary outcomes

  1. Change in QT and corrected QT (QTc) interval compared to baseline

    Time frame: 8 weeks

Secondary outcomes

  1. Change in upper gastrointestinal symptom severity index compared to baseline.

    Time frame: 8 weeks

06

Study locations

16 sites
  • Başkent University Hospital Gastroenterology Dep.
    Adana, Turkey
  • Çukurova University Medical Faculty Cardiology Dep.
    Adana, 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.
    Ankara, Turkey
  • Antalya Research and Training Hospital Gastroenterology Dep.
    Antalya, Turkey
  • Balıkesir University Medical Faculty Gastroenterology Dep.
    Balıkesir, Turkey
  • Gaziantep Şahinbey Research and Training Hospital Gastroenterology Dep.
    Gaziantep, Turkey
  • Dr. Sadi Konuk Research and Training Hospital Gastroenterology Dep.
    Istanbul, Turkey
  • Ümraniye Research and Training Hospital Gastroenterology Dep.
    Istanbul, Turkey
  • Ege University Medical Faculty Gastroenterology Dep.
    İzmir, Turkey
  • Tepecik Research and Training Hospital Gastroenterology Dep.
    İzmir, Turkey
  • Celal Bayar University Medical Faculty Gastroenterology Dep.
    Manisa, Turkey
  • Sıtkı Koçman University Medical Faculty Gastroenterology Dep.
    Muğla, Turkey
  • Recep Tayyip Erdoğan University Medical Faculty Gastroenterology Dep.
    Rize, Turkey
  • Cumhuriyet University Medical Faculty Gastroenterology Dep.
    Sivas, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03355170
Lead sponsor
Neutec Ar-Ge San ve Tic A.Ş
Responsible party
Sponsor
First posted
Nov 28, 2017
Start date
Mar 1, 2018 (estimated)
Primary completion
Dec 1, 2018
Completion
Jan 1, 2019
Last update
Jan 5, 2023

Study contacts

Serhat Bor, Prof Dr
study chair · Ege University Medical Faculty Gastroenterology Dep.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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