The Effect of Dexrabeprazole on Intragastric and Intraesophageal Acidity

NCT02689999 | Completed Phase 4

• 1 other identifier: NEU-01.15
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

Gastroesophageal Reflux Disease (GERD), GERD, impedence

Outcome Measures

Primary Outcomes (2)

• - The percent of pH < 4 duration of 24-hour intragastric acidity and intraesophageal acidity after seven-days treatment.

  Multichannel intraluminal esophageal impedance pH-meter will be applied to cases in screening and second visit in order to evaluate the effect on 24-hour intragastric and intraesophageal acid values. 24-hour pH values of cases will be measured with pH-meter. Combined impedence pH catheter will be placed to 10 cm under and 5 cm upper of inferior esophageal sphincter of cases under local anesthesia. Cases will be informed about adherence to the diet list, not to take anti-acids and need to press symptom button on device when complaints occur during 24-hour measurements. After 24 hours, results will be recorded and reported by transferring to computer environment. These results will be compared with measurement obtained in screening visit and then efficacy assessment will be done.

  One week

• - The area under curve (AUC) of pH < 4 duration of 24-hour intragastric acidity and intraesophageal acidity after seven-days treatment.

  Multichannel intraluminal esophageal impedance pH-meter will be applied to cases in screening and second visit in order to evaluate the effect on 24-hour intragastric and intraesophageal acid values. 24-hour pH values of cases will be measured with pH-meter. Combined impedence pH catheter will be placed to 10 cm under and 5 cm upper of inferior esophageal sphincter of cases under local anesthesia. Cases will be informed about adherence to the diet list, not to take anti-acids and need to press symptom button on device when complaints occur during 24-hour measurements. After 24 hours, results will be recorded and reported by transferring to computer environment. These results will be compared with measurement obtained in screening visit and then efficacy assessment will be done.

  One week

Study Arms (1)

Dexrabeprazole 10 mg Enteric-Coated Tablets

EXPERIMENTAL

Dexrabeprazole 10 mg Enteric-Coated Tablets / once daily

Drug: Dexrabeprazole 10 mg Enteric-Coated Tablets

Interventions

Dexrabeprazole 10 mg Enteric-Coated Tablets DRUG

Dexrabeprazole 10 mg Enteric-Coated Tablets

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of gastroesophageal reflux disease (GERD) in presence of pyrosis and/or regurgitation 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 of overlapping 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 performed before 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 not performed in endoscopy, stool antigen test or urease breath test should be performed and Helicobacter pylori should be negative.

You may not qualify if:

• Presence of food in stomach in gastrointestinal system (GIS) endoscopy performed in last 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-dependent diabetes mellitus (IDDM), symptomatic gallbladder stone (cases who are asymptomatic and are not undergo cholecystitis and whose stone is 3 cm or polyp is smaller than 1 cm may be included), active or unhealed stomach or duodenum ulcer, Zollinger-Ellison syndrome, primary esophagus motility disorders, pancreatitis, inflammatory bowel disease, chronic liver disease, severe liver disease, uncontrolled renal impairment, presence of cancer except non-melanoma skin cancer, heart failure, cerebrovascular disease, epilepsy,
• Major psychiatric disease,
• Alcoholism or cases take narcotics,
• Pathologic laboratory test; hemogram, sedimentation, C-reactive protein (CRP), thyroid function 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 or acid release,
• Cases undergo abdominal operation; hysterectomy, abdominal hernia operation, caesarean, appendectomies may be included but all types of cholecystectomy will be excluded.
• Cases taking a proton pomp inhibitor (PPI) and H2 blocker for last seven days and prokinetic drug for last three days,
• Condition that taking drugs need stomach acid for optimal absorption; such as ketoconazole, iron salts, digoxin, ampicillin esters, anticoagulants, antineoplastic agents.
• Cases who must take prostaglandin analogs,
• Cases who must take non-steroidal anti-inflammatory drug (NSAID) during study,
• Cases taking antidepressants,

Sponsors & Collaborators

• Neutec Ar-Ge San ve Tic A.Ş: lead

Study Sites (3)

Ege University Gastroenterology Department

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Ankara University Gastroenterology Department

Ankara, Turkey (Türkiye)

Location

On Dokuz Mayıs University Gastroenterology Department

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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: February 10, 2016
• First Posted: February 24, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 24, 2017

Record last verified: 2017-08

Locations

TU (3)