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Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole and Esomeprazole for GERD Grade A and B

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ClinicalTrials.gov Identifier: NCT03128736
Recruitment Status : Completed
First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary:
Rapid onset of proton-pump inhibitors to achieve a fast symptom is an unmet need in treating gastroesophageal reflux disease (GERD) but there was no report on the short-term clinical effects and timing to symptom relief comparing dexlansoprazole 60 mg to esomeprazole 40 mg. This pilot study aims to compare the one-week clinical effects of single doses of the two drugs in treating GERD patients.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: Esomeprazole group Drug: Dexlansoprazole group Phase 4

Detailed Description:
A comparative study to different PPIs in pharmacokinetic change showing that after 12-24 hours post dose, mean percentage of time with pH > 4 and average of mean pH were greater for dexlansoprazole than esomeprazole . However, the study did not report the clinical effect after tablets used. There was no report on the short-term clinical effects and timing to symptom relief of gastroesophageal reflux disease (GERD) between dexlansoprazole 60 mg and esomeprazole 40 mg. Therefore, we conducted a randomized controlled, open-label, study to compare the 7-day clinical effects of single doses of dexlansoprazole 60 mg and esomeprazole 40 mg in for GERD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole 60 mg and Esomeprazole 40 mg for Gastroesophageal Reflux Disease Grade A and B
Actual Study Start Date : April 1, 2014
Actual Primary Completion Date : February 28, 2016
Actual Study Completion Date : March 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: dexlansoprazole group
dexlansoprazole 60mg
Drug: Dexlansoprazole group
Dexlansoprazole 60mg qd
Other Name: Dexilant

Experimental: esomeprazole group
esomeprazole 40mg
Drug: Esomeprazole group
Esomeprazole 40mg qd
Other Name: Nexium




Primary Outcome Measures :
  1. Rate of complete symptom resolution (CSR) [ Time Frame: 1 week after finishing study drug ]
    Evaluate the complete symptom resolution by questionnaire


Secondary Outcome Measures :
  1. Rate of symptom relapse [ Time Frame: 12 weeks after finishing study drug ]
    Symptom relapse is defined as (a) two or more episodes of reflux symptoms per week that impair the quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy were recruited

Exclusion Criteria:

  • taking antisecretory agents, such as PPIs and histamine-2 receptor antagonists within 2 week prior to the endoscopy
  • coexistence of peptic ulcer or gastrointestinal malignancies
  • pregnancy
  • coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia),
  • previous gastric surgery
  • allergy to dexlansoprazole or esomeprazole
  • symptom score of a validated questionnaire (Chinese GERDQ) less than 12

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): NCT03128736


Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Deng-Chyang Wu, MD, PhD Kaohsiung Medical University
Principal Investigator: Seng-Kee Chuah, MD Chang Gung Memorial Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT03128736     History of Changes
Other Study ID Numbers: KMUHIRB-2014-09-02(I)
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Esomeprazole
Dexlansoprazole
Lansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action