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

This study has been withdrawn prior to enrollment.
(patients could not be recuited within study duration)
Sponsor:
Information provided by (Responsible Party):
Eun Hee Seo, Inje University
ClinicalTrials.gov Identifier:
NCT01391715
First received: July 11, 2011
Last updated: January 16, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: rabeprazole
Drug: standard dose rabeprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • symptom improvement at 2 week after double dose rabeprazole treatment [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]
    symptom improvement according to FSSG(the frequency scale for the symptoms of GERD) at 2 week after double dose rabeprazole treatment


Secondary Outcome Measures:
  • sustained symptom improvement at 6 week after treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    sustained symptom improvement assessed by FSSG(the frequency scale for the symptoms of GERD)score at 6 week after treatment


Enrollment: 0
Study Start Date: August 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Double dose rabeprazole
Rabeprazole 20m bid per day will be given for 2 weeks
Drug: rabeprazole
rabeprazole 20mg bid per day for 2 weeks
Placebo Comparator: standard dose rabeprazole
rabeprazole 20mg per day will bi given for 2 weeks
Drug: standard dose rabeprazole
rabeprazole 20mg qd per day for 2 weeks

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391715

Locations
Korea, Republic of
Haeundae Paik Hospital, Inje University School of Medicine
Busan, Korea, Republic of, 612-030
Sponsors and Collaborators
Inje University
Investigators
Study Director: Tae Oh Kim, M.D. PhD. Internal Medicine, Haeundae Paik Hospital
Principal Investigator: Eun Hee Seo, M.D Internal Medicine, Haeundae Paik Hospital
  More Information

No publications provided

Responsible Party: Eun Hee Seo, Fellow, Inje University
ClinicalTrials.gov Identifier: NCT01391715     History of Changes
Other Study ID Numbers: 01July2011
Study First Received: July 11, 2011
Last Updated: January 16, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Inje University:
Gastroesophageal reflux disease
Proton pump inhibitor
standard dose
Double dose

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rabeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014