The Efficacy of Lansoprazole and Domperidone Combination on Intragastric and Intraesophageal Acidity
NCT ID: NCT02958046
Last Updated: 2016-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2014-01-31
2015-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lansoprazole/Domperidone
DUOLANS 30/30 mg SR tablet per oral, one tablet daily
Lansoprazole/Domperidone
DUOLANS 30/30 mg SR tablet per oral, one tablet daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lansoprazole/Domperidone
DUOLANS 30/30 mg SR tablet per oral, one tablet daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
Exclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Neutec Ar-Ge San ve Tic A.Ş
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Neutec Ar-Ge San ve Tic A.S
Role: STUDY_DIRECTOR
Neutec Ar-Ge Clinical Trial
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department Of Gastroenterology, Faculty Of Medicine, Ege University, Izmir, Turkey
Izmir, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Neu-01.13
Identifier Type: -
Identifier Source: org_study_id