Completed

Phase 4 Study, Assessing the Efficacy of Lansoprazole and Domperidone Combination on Intragastric and Intraesophageal Acidity

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What is being tested

Lansoprazole/Domperidone

Drug
Who is being recruted

Deglutition Disorders+3

+ Digestive System Diseases

+ Esophageal Diseases

From 18 to 65 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2014
See protocol details

Summary

Principal SponsorNeutec Ar-Ge San ve Tic A.Ş
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2014

Actual date on which the first participant was enrolled.

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.

Official TitlePhase 4 Study, Assessing the Efficacy of Lansoprazole and Domperidone Combination on Intragastric and Intraesophageal Acidity
NCT02958046
Principal SponsorNeutec Ar-Ge San ve Tic A.Ş
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Deglutition DisordersDigestive System DiseasesEsophageal DiseasesGastroesophageal RefluxGastrointestinal DiseasesEsophageal Motility Disorders

Criteria

6 inclusion criteria required to participate
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
Show More Criteria
17 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
DUOLANS 30/30 mg SR tablet per oral, one tablet daily

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department Of Gastroenterology, Faculty Of Medicine, Ege University, Izmir, Turkey

Izmir, Turkey (Türkiye)Open Department Of Gastroenterology, Faculty Of Medicine, Ege University, Izmir, Turkey in Google Maps
CompletedOne Study Center