Gastroesophageal Reflux DiseasePhase 4NCT02958046
The Efficacy of Lansoprazole and Domperidone Combination on Intragastric and Intraesophageal Acidity
A Phase 4 study testing Lansoprazole/Domperidone in people with Gastroesophageal Reflux Disease, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the efficacy of lansoprazole combination with domperidone on intragastric acidity and intraesophageal acidity, GERD symptoms, impedance kinetics, gastric emptying in patients with gastroesophageal reflux disease (GERD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Lansoprazole/Domperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Aug 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of GERD with symptoms (i.e. regurgitation, pyrosis) during last one year with at least 1 or more episodes a week
- Age ≥ 18 years and <65 years
- Helicobacter pylori (an infection) negative
- Have a body mass index (BMI) between 18 and 33 kg/m²
- pH>4 gastric exposure <25% on a 24-hour dual pH channel monitoring study performed prior to screening (normal intragastric pH +2SD)
- Pathologic intraesophageal acidity exposure (DeMeester score >14.75 and/or >4% of pH<4 (at least 21 hours measured)
Who cannot join
- Have food existence at stomach during upper GIS endoscopy, Barrett's stricture, GIS bleeding, malignite, and all type of GIS pathology to affects the study
- Have allergy to the study drug or any of the excipients of the formulation
- Must use of pain relieving medications (NSAIDs) during study, (paracetamol not excess of 2 gram/day can be used)
- Use of any concomitant therapy which are drug affects the motility of GIS and acid secretion
- Use of prostaglandin analogs and sucralfate
- Have taken PPIs or H2-blockers within 7 days and prokinetic drugs within 3 days before entering the study
Show all 17Show fewer
- History of surgery of cholecystectomy
- Abusing drugs or alcohol
- Have a major psychiatric disease
- Use of antidepressant (patient with minor depression or under controlled with drug can be included)
- Have suppressed immune system or taken a immunosupressive treatment, including cortisone.
- Have malabsorption, gastric outlet obstruction that affects the absorption of drug
- Must use of drug ketoconazole, iron salts, digoxin, ampicilin esters , anticoagulants, antineoplastic agents
- Women who are pregnant or of childbearing
- Have gastroparesis
- Current or a history of cancer, with the exception of fully excised skin carcinoma (Malign Melanoma will be excluded).
- Have severe concomitant disease (i.e. uncontrolled or insuline dependent diabetes mellitus, symptomatic bladder stone (patients have asemptomatic, not undergone colesistit, stone <3cm and polib <1cm can be included), active or unhealed gastric or duodenum ulcer, Zollinger Ellison syndrome, primary esophageal motility disorder, pancreatitis, inflammatory bowel disease, chronic hepatic disease, severe lung disease, uncontrolled kidney failure, cardiac failure, cerebrovascular disease, epilepsy) which affects the conduct and result of study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department Of Gastroenterology, Faculty Of Medicine, Ege University, Izmir, Turkey
Izmir
About this study
Official title: Phase 4 Study, Assessing the Efficacy of Lansoprazole and Domperidone Combination on Intragastric and Intraesophageal Acidity
The purpose of this study is to investigate the efficacy of lansoprazole combination with domperidone on intragastric acidity and intraesophageal acidity, GERD symptoms, impedance kinetics, gastric emptying in patients with gastroesophageal reflux disease (GERD).
Read the detailed description
Objectives of the trial to assess the efficacy of lansoprazole in combination with domperidone on gastric acidity, intraesophageal acidity, GERD symptoms, impedance kinetics and gastric emptying in patients with GERD.
24 hour pH measurement and gastric emptying test will be done at screening visit and after 7 days of drug treatment. Twelve patients will take one tablet for 7 days.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Lansoprazole/Domperidone
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lansoprazole/DomperidoneDrug
Also called Duolans
DUOLANS 30/30 mg SR tablet per oral, one tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Lansoprazole/Domperidone | Experimental | DUOLANS 30/30 mg SR tablet per oral, one tablet daily Receives: Drug: Lansoprazole/Domperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage time of 24-hour intragastric pH >4 compared to baseline
Measured: 7 days
The AUC of 24-hour intragastric pH >4 compared to baseline
Measured: 7 days
Secondary outcomes (12)
The significant increase in total measurements of median pH
Measured: 7 days
The significant increase in nocturnal measurements of median pH
Measured: 7 days
The decrease in reflux symptom index calculated by weekly regurgitation numbers
Measured: 7 days
The decrease in reflux symptom index calculated by weekly pyrosis numbers
Measured: 7 days
The percentage time of 24-hour intragastric pH >2 compared to baseline
Measured: 7 days
The percentage time of 24-hour intragastric pH >6 compared to baseline
Measured: 7 days
The AUC of 24-hour intragastric pH >2 compared to baseline
Measured: 7 days
The AUC of 24-hour intragastric pH >6 compared to baseline
Measured: 7 days
The percentage time of 24-hour total intragastric pH >4 compared to baseline
Measured: 7 days
The AUC of 24-hour total intragastric pH >4 compared to baseline
Measured: 7 days
The evaluation of gastric emptying by octanoic acid breath test compared to baseline
Measured: 7 days
The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startJan 2014
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- Neutec Ar-Ge San ve Tic A.S, Study director, Neutec Ar-Ge Clinical Trial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958046
- Sponsor's protocol ID
- Neu-01.13
- Status last verified
- Oct 2016
- First submitted
- 1 Sep 2015
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study, Assessing the Efficacy of Lansoprazole and Domperidone Combination on Intragastric and Intraesophageal Acidity
- ClinicalTrials.gov ID
- NCT02958046
- Acronym / sponsor ID
- Neu-01.13
- Conditions
- Gastroesophageal Reflux Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Nov 2016 (estimated)
- 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 purpose of this study is to investigate the efficacy of lansoprazole combination with domperidone on intragastric acidity and intraesophageal acidity, GERD symptoms, impedance kinetics, gastric emptying in patients with gastroesophageal reflux disease (GERD).
Detailed description
Objectives of the trial to assess the efficacy of lansoprazole in combination with domperidone on gastric acidity, intraesophageal acidity, GERD symptoms, impedance kinetics and gastric emptying in patients with GERD.
24 hour pH measurement and gastric emptying test will be done at screening visit and after 7 days of drug treatment. Twelve patients will take one tablet for 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lansoprazole/Domperidone | Experimental | Drug: Lansoprazole/DomperidoneDUOLANS 30/30 mg SR tablet per oral, one tablet daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of GERD with symptoms (i.e. regurgitation, pyrosis) during last one year with at least 1 or more episodes a week
- Age ≥ 18 years and <65 years
- Helicobacter pylori (an infection) negative
- Have a body mass index (BMI) between 18 and 33 kg/m²
- pH>4 gastric exposure <25% on a 24-hour dual pH channel monitoring study performed prior to screening (normal intragastric pH +2SD)
Key exclusion criteria (17 listed)
- Have food existence at stomach during upper GIS endoscopy, Barrett's stricture, GIS bleeding, malignite, and all type of GIS pathology to affects the study
- Have allergy to the study drug or any of the excipients of the formulation
- Must use of pain relieving medications (NSAIDs) during study, (paracetamol not excess of 2 gram/day can be used)
- Use of any concomitant therapy which are drug affects the motility of GIS and acid secretion
- Use of prostaglandin analogs and sucralfate
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: DuolansDUOLANS 30/30 mg SR tablet per oral, one tablet daily | Drug | Lansoprazole/Domperidone |
Primary outcome
The percentage time of 24-hour intragastric pH >4 compared to baseline
Time frame: 7 days
The AUC of 24-hour intragastric pH >4 compared to baseline
Time frame: 7 days
12 secondary outcomes
The significant increase in total measurements of median pH
Time frame: 7 days
The significant increase in nocturnal measurements of median pH
Time frame: 7 days
The decrease in reflux symptom index calculated by weekly regurgitation numbers
Time frame: 7 days
The decrease in reflux symptom index calculated by weekly pyrosis numbers
Time frame: 7 days
The percentage time of 24-hour intragastric pH >2 compared to baseline
Time frame: 7 days
The percentage time of 24-hour intragastric pH >6 compared to baseline
Time frame: 7 days
The AUC of 24-hour intragastric pH >2 compared to baseline
Time frame: 7 days
The AUC of 24-hour intragastric pH >6 compared to baseline
Time frame: 7 days
The percentage time of 24-hour total intragastric pH >4 compared to baseline
Time frame: 7 days
The AUC of 24-hour total intragastric pH >4 compared to baseline
Time frame: 7 days
The evaluation of gastric emptying by octanoic acid breath test compared to baseline
Time frame: 7 days
The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
Neutec Ar-Ge San ve Tic A.S study director
Neutec Ar-Ge Clinical Trial
1 site 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 in people with Gastroesophageal Reflux Disease, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The percentage time of 24-hour intragastric pH >4 compared to baseline (time frame: 7 days). The study lists 2 primary outcomes in all. 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 8 Nov 2016.