The Effect of Dexrabeprazole on Intragastric and Intraesophageal Acidity

Last updated: August 23, 2017
Sponsor: Neutec Ar-Ge San ve Tic A.Ş
Overall Status: Completed

Phase

4

Condition

Functional Dyspepsia

Heartburn

Esophageal Disorders

Treatment

N/A

Clinical Study ID

NCT02689999
NEU-01.15
  • Ages 18-70
  • All Genders

Study Summary

It is planned to investigate the effect of dexrabeprazole on gastric acid primarily, and then gastroesophageal reflux disease (GERD) symptoms, intraesophageal acidity (reflux) and impedance kinetics.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of gastroesophageal reflux disease (GERD) in presence of pyrosis and/orregurgitation occurs once a week or more.

  • Esophagitis stage A-B according to Los Angeles classification,

  • Major symptom should be gastroesophageal reflux disease (GERD) in presence ofoverlapping symptoms,

  • Age range should be 18-70 years,

  • BMI should be 18-33 kg/m2,

  • Presence of sufficient gastric acidity: Cases which intragastric ph > 4 value is under 25% according to dual multichannel intraluminal impedance-pH MII monitoring performedbefore study initiation,

  • Pathologic intraesophageal acid exposure; DeMeester score > 14.75 and/or ph < 4 value > 4% (according to at 21 hour measurement at least),

  • Helicobacter pylori should be negative according to biopsy in gastrointestinal system (GIS) endoscopy performed in last 12 months before study initiation; if biopsy notperformed in endoscopy, stool antigen test or urease breath test should be performedand Helicobacter pylori should be negative.

Exclusion

Exclusion Criteria:

  • Presence of food in stomach in gastrointestinal system (GIS) endoscopy performed inlast 12 months before study initiation, all types of gastrointestinal system (GIS)pathology such as Barret stricture, stomach channel obstruction, malignity,gastrointestinal system (GIS) bleeding and cases with > 3 cm Hiatus hernia.

  • Presence of severe chronic comorbid diseases; uncontrolled or insulin-dependentdiabetes mellitus (IDDM), symptomatic gallbladder stone (cases who are asymptomaticand are not undergo cholecystitis and whose stone is 3 cm or polyp is smaller than 1cm may be included), active or unhealed stomach or duodenum ulcer, Zollinger-Ellisonsyndrome, primary esophagus motility disorders, pancreatitis, inflammatory boweldisease, chronic liver disease, severe liver disease, uncontrolled renal impairment,presence of cancer except non-melanoma skin cancer, heart failure, cerebrovasculardisease, epilepsy,

  • Major psychiatric disease,

  • Alcoholism or cases take narcotics,

  • Pathologic laboratory test; hemogram, sedimentation, C-reactive protein (CRP), thyroidfunction tests, liver enzymes,

  • Malabsorption that may affect drug absorption,

  • Immunosuppressive and cortisone taking cases,

  • Pregnancy or positive pregnancy test and lactating women,

  • Cases taking all types of drugs which may affect gastrointestinal system motility oracid release,

  • Cases undergo abdominal operation; hysterectomy, abdominal hernia operation,caesarean, appendectomies may be included but all types of cholecystectomy will beexcluded.

  • Cases taking a proton pomp inhibitor (PPI) and H2 blocker for last seven days andprokinetic drug for last three days,

  • Condition that taking drugs need stomach acid for optimal absorption; such asketoconazole, iron salts, digoxin, ampicillin esters, anticoagulants, antineoplasticagents.

  • Cases who must take prostaglandin analogs,

  • Cases who must take non-steroidal anti-inflammatory drug (NSAID) during study,

  • Cases taking antidepressants,

  • Cases who refuse to sign informed consent,

  • Hypersensitivity to study drug.

Study Design

Total Participants: 12
Study Start date:
February 01, 2016
Estimated Completion Date:
August 31, 2017

Study Description

The participants will be on one week medication after two-weeks observation period. Intragastric and intraesophageal multichannel intraluminal impedance-pH (pH-MII) monitoring will be performed before and after medication. The pre- and post-treatment data will be compared. The safety tests will be performed during study in terms of possible side effects.

Connect with a study center

  • Ege University Gastroenterology Department

    Izmir, Bornova 35100
    Turkey

    Site Not Available

  • Ankara University Gastroenterology Department

    Ankara,
    Turkey

    Site Not Available

  • On Dokuz Mayıs University Gastroenterology Department

    Samsun,
    Turkey

    Site Not Available

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