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

Gastroesophageal Reflux Disease Clinical Trial

— DRNERD  

Official title:

Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD: a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01391715
• Other study ID #: 01July2011
• Status: Withdrawn
• Phase: Phase 3
• First received: July 11, 2011
• Last updated: January 16, 2012
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2012
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• rabeprazole
rabeprazole 20mg bid per day for 2 weeks
• standard dose rabeprazole
rabeprazole 20mg qd per day for 2 weeks

Locations

Country	Name	City	State
Korea, Republic of	Haeundae Paik Hospital, Inje University School of Medicine	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom improvement at 2 week after double dose rabeprazole treatment	symptom improvement according to FSSG(the frequency scale for the symptoms of GERD) at 2 week after double dose rabeprazole treatment	Two weeks	Yes
Secondary	sustained symptom improvement at 6 week after treatment	sustained symptom improvement assessed by FSSG(the frequency scale for the symptoms of GERD)score at 6 week after treatment	6 weeks	Yes