NCT02958046

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2015

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
Last Updated

November 8, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

September 1, 2015

Last Update Submit

November 4, 2016

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (2)

  • The percentage time of 24-hour intragastric pH >4 compared to baseline

    7 days

  • The AUC of 24-hour intragastric pH >4 compared to baseline

    7 days

Secondary Outcomes (12)

  • The significant increase in total measurements of median pH

    7 days

  • The significant increase in nocturnal measurements of median pH

    7 days

  • The decrease in reflux symptom index calculated by weekly regurgitation numbers

    7 days

  • The decrease in reflux symptom index calculated by weekly pyrosis numbers

    7 days

  • The percentage time of 24-hour intragastric pH >2 compared to baseline

    7 days

  • +7 more secondary outcomes

Study Arms (1)

Lansoprazole/Domperidone

EXPERIMENTAL

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

Drug: Lansoprazole/Domperidone

Interventions

Lansoprazole/DomperidoneDRUG

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

Also known as: Duolans
Lansoprazole/Domperidone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

LansoprazoleDomperidone

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPiperidines

Study Officials

  • Neutec Ar-Ge San ve Tic A.S

    Neutec Ar-Ge Clinical Trial

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2015

First Posted

November 8, 2016

Study Start

January 1, 2014

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

November 8, 2016

Record last verified: 2016-10

Locations

TU(1)