Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD

Last updated: January 16, 2012
Sponsor: Inje University
Overall Status: Trial Not Available

Phase

3

Condition

Esophageal Disorders

Heartburn (Pediatric)

Gastroesophageal Reflux Disease (Gerd)

Treatment

N/A

Clinical Study ID

NCT01391715
01July2011
  • Ages > 18
  • All Genders

Study Summary

To the best of our knowledge, there has been no randomized controlled trial to compare double dose PPI therapy with standard one dose PPI therapy for NERD patients. Thus, we hypothesize that a double dose PPI would accelerate and sustain the control of symptom in NERD patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • heartburn and/or reflux at least twice weekly in the absence of visible esophagealmucosal breaks at endoscopy

Exclusion

Exclusion Criteria:

  • pregnancy

  • lactation

  • Hx of gastric surgery

  • Hx of gastric cancer or peptic ulcer

  • major medical problems (including CHF, renal failure, COPD, asthma, liver cirrhosis)

  • severe systemic illness

  • Hx of malignancy, allergy Hx to rabeprazole

  • patients who had taken antibiotics

  • antisecretory agents including H2-blocker

  • PPI within 4 weeks before endoscopy

  • current usage of steroids, NSAIDs, aspirin, anticoagulant medication

Study Design

Study Start date:
August 01, 2011
Estimated Completion Date:
December 31, 2012

Study Description

In Asian, the majority of GERD cases are cases of nonerosive reflux esophagitis(NERD). NERD is a difficult -to-treat acid reflux condition even with PPI compared to reflux esophagitis(RE). In addition, the quality of life of NERD patients is quite low, NERD patients need quicker and more effective treatment options. At present, PPI-based step-down treatment is recommended for GERD patients. Doubling th PPI dose has become a commonly practiced therapeutic strategy in patients with GERD who failed PPI once daily. In patients with symptomatic GERD who failed the one dose PPI can increase the rate of overall symptom improvement by 22-26%. There are various mechanisms for standard dose PPI failure in GERD patients. Esophageal hypersensitivity is likely the underlying mechanism in a significant number of patients. Patients with the sensitive esophagus (normal endoscopy and pH test but positive symptom index) were more likely to respond to PPI twice a day. It is thus of clinical interest to determine whether an increased dosage of PPI can achieve rapidly the control of symptoms for patient with NERD patients.

Connect with a study center

  • Haeundae Paik Hospital, Inje University School of Medicine

    Busan, 612-030
    Korea, Republic of

    Site Not Available

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