The Efficacy of Lansoprazole and Domperidone Combination on Intragastric and Intraesophageal Acidity

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02958046
• Other study ID #: Neu-01.13
• Status: Completed
• Phase: Phase 4
• First received: September 1, 2015
• Last updated: November 4, 2016
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: October 2016
• Source: Neutec Ar-Ge San ve Tic A.S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

• 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Lansoprazole/Domperidone
DUOLANS 30/30 mg SR tablet per oral, one tablet daily

Locations

Country	Name	City	State
Turkey	Department Of Gastroenterology, Faculty Of Medicine, Ege University, Izmir, Turkey	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Neutec Ar-Ge San ve Tic A.S

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage time of 24-hour intragastric pH >4 compared to baseline		7 days	No
Primary	The AUC of 24-hour intragastric pH >4 compared to baseline		7 days	No
Secondary	The significant increase in total measurements of median pH		7 days	No
Secondary	The significant increase in nocturnal measurements of median pH		7 days
Secondary	The decrease in reflux symptom index calculated by weekly regurgitation numbers		7 days	No
Secondary	The decrease in reflux symptom index calculated by weekly pyrosis numbers		7 days
Secondary	The percentage time of 24-hour intragastric pH >2 compared to baseline		7 days	No
Secondary	The percentage time of 24-hour intragastric pH >6 compared to baseline		7 days	No
Secondary	The AUC of 24-hour intragastric pH >2 compared to baseline		7 days	No
Secondary	The AUC of 24-hour intragastric pH >6 compared to baseline		7 days	No
Secondary	The percentage time of 24-hour total intragastric pH >4 compared to baseline		7 days	No
Secondary	The AUC of 24-hour total intragastric pH >4 compared to baseline		7 days	No
Secondary	The evaluation of gastric emptying by octanoic acid breath test compared to baseline		7 days	No
Secondary	The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment)		7 days	Yes