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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02958046
Recruitment Status : Completed
First Posted : November 8, 2016
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Neutec Ar-Ge San ve Tic A.Ş

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).

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: Lansoprazole/Domperidone Phase 4

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 4 Study, Assessing the Efficacy of Lansoprazole and Domperidone Combination on Intragastric and Intraesophageal Acidity
Study Start Date : January 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Heartburn

Arm Intervention/treatment
Experimental: Lansoprazole/Domperidone
DUOLANS 30/30 mg SR tablet per oral, one tablet daily
Drug: Lansoprazole/Domperidone
DUOLANS 30/30 mg SR tablet per oral, one tablet daily
Other Name: Duolans




Primary Outcome Measures :
  1. The percentage time of 24-hour intragastric pH >4 compared to baseline [ Time Frame: 7 days ]
  2. The AUC of 24-hour intragastric pH >4 compared to baseline [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. The significant increase in total measurements of median pH [ Time Frame: 7 days ]
  2. The significant increase in nocturnal measurements of median pH [ Time Frame: 7 days ]
  3. The decrease in reflux symptom index calculated by weekly regurgitation numbers [ Time Frame: 7 days ]
  4. The decrease in reflux symptom index calculated by weekly pyrosis numbers [ Time Frame: 7 days ]
  5. The percentage time of 24-hour intragastric pH >2 compared to baseline [ Time Frame: 7 days ]
  6. The percentage time of 24-hour intragastric pH >6 compared to baseline [ Time Frame: 7 days ]
  7. The AUC of 24-hour intragastric pH >2 compared to baseline [ Time Frame: 7 days ]
  8. The AUC of 24-hour intragastric pH >6 compared to baseline [ Time Frame: 7 days ]
  9. The percentage time of 24-hour total intragastric pH >4 compared to baseline [ Time Frame: 7 days ]
  10. The AUC of 24-hour total intragastric pH >4 compared to baseline [ Time Frame: 7 days ]
  11. The evaluation of gastric emptying by octanoic acid breath test compared to baseline [ Time Frame: 7 days ]
  12. The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment) [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958046


Locations
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Turkey
Department Of Gastroenterology, Faculty Of Medicine, Ege University, Izmir, Turkey
İzmir, Turkey
Sponsors and Collaborators
Neutec Ar-Ge San ve Tic A.Ş
Investigators
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Study Director: Neutec Ar-Ge San ve Tic A.S Neutec Ar-Ge Clinical Trial

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Responsible Party: Neutec Ar-Ge San ve Tic A.Ş
ClinicalTrials.gov Identifier: NCT02958046     History of Changes
Other Study ID Numbers: Neu-01.13
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Domperidone
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents