GERDPhase 4NCT03355170
Cardiac Safety of Lansoprazole and Domperidon Combination
A Phase 4 study testing Lansoprazole/Domperidone and Lansoprazole in people with GERD and Cardiac Event, run by Neutec Ar-Ge San ve Tic A.Ş at 16 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- GERD, Cardiac Event, Safety Issues
- What is being tested?
- Lansoprazole/Domperidone and Lansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 16 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- GERD patients with BMI 18-33 kg/m2
- Patients with esophagitis class A-B according to Los Angeles classification
Who cannot join
- 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).
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- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Turkey (Türkiye)16 sites
Başkent University Hospital Gastroenterology Dep.
Adana
Çukurova University Medical Faculty Cardiology Dep.
Adana
Ankara University Medical Faculty Gastroenterology Dep.
Ankara
Dışkapı Research and Training Hospital Gastroenterology Dep.
Ankara
Yüksek İhtisas Research and Training Hospital Gastroenterology Dep.
Ankara
Antalya Research and Training Hospital Gastroenterology Dep.
Antalya
Balıkesir University Medical Faculty Gastroenterology Dep.
Balıkesir
Gaziantep Şahinbey Research and Training Hospital Gastroenterology Dep.
Gaziantep
Dr. Sadi Konuk Research and Training Hospital Gastroenterology Dep.
Istanbul
Ümraniye Research and Training Hospital Gastroenterology Dep.
Istanbul
Ege University Medical Faculty Gastroenterology Dep.
Izmir
Tepecik Research and Training Hospital Gastroenterology Dep.
Izmir
Celal Bayar University Medical Faculty Gastroenterology Dep.
Manisa
Sıtkı Koçman University Medical Faculty Gastroenterology Dep.
Muğla
Recep Tayyip Erdoğan University Medical Faculty Gastroenterology Dep.
Rize
Cumhuriyet University Medical Faculty Gastroenterology Dep.
Sivas
About this study
Official title: 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.
- Conditions
- GERD, Cardiac Event, Safety Issues
- Being tested
- Lansoprazole/Domperidone, Lansoprazole
- Medical subject headings
- Gastroesophageal Reflux, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lansoprazole/DomperidoneCombination product
Also called Duolans
Experimental
LansoprazoleDrug
Also called Lasotab
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| Lansoprazole/Domperidone | Experimental | 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. Receives: Combination Product: Lansoprazole/Domperidone |
| Lansoprazole | Active comparator | Patient will be administered lansoprazole 30 mg capsules (brand name: Lasotab) half an hour before breakfast for eight weeks according to randomisation scheme. Receives: Drug: Lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QT and corrected QT (QTc) interval compared to baseline
Measured: 8 weeks
Secondary outcomes (1)
Change in upper gastrointestinal symptom severity index compared to baseline.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Mar 2018 (estimated)
- Primary completion1 Dec 2018
- Study completion1 Jan 2019
Why it stopped: The sponsor decided to continue with a different design and a different protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.Ş
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Serhat Bor, Prof Dr, Study chair, Ege University Medical Faculty Gastroenterology Dep.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355170
- Sponsor's protocol ID
- NEU-05.16
- Status last verified
- Jan 2023
- First submitted
- 20 Nov 2017
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Safety Evaluation of Lansoprazole/Domperidone 30/30 mg Sustained Release Capsule Formulation
- ClinicalTrials.gov ID
- NCT03355170
- Acronym / sponsor ID
- NEU-05.16
- Conditions
- GERD, Cardiac Event, Safety Issues
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor decided to continue with a different design and a different protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lansoprazole/Domperidone | Experimental | Combination Product: Lansoprazole/DomperidonePatient 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 comparator | Drug: LansoprazolePatient will be administered lansoprazole 30 mg capsules (brand name: Lasotab) half an hour before breakfast for eight weeks according to randomisation scheme. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- GERD patients with BMI 18-33 kg/m2
- Patients with esophagitis class A-B according to Los Angeles classification
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lansoprazole/DomperidoneAlso: DuolansExperimental | Combination product | Lansoprazole/Domperidone |
| LansoprazoleAlso: LasotabActive comparator | Drug | Lansoprazole |
Primary outcome
Change in QT and corrected QT (QTc) interval compared to baseline
Time frame: 8 weeks
1 secondary outcome
Change in upper gastrointestinal symptom severity index compared to baseline.
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serhat Bor, Prof Dr study chair
Ege University Medical Faculty Gastroenterology Dep.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lansoprazole/Domperidone and Lansoprazole in people with GERD and Cardiac Event, run by Neutec Ar-Ge San ve Tic A.Ş at 16 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QT and corrected QT (QTc) interval compared to baseline (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.