Clinical trial NCT01391715: Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD
Official title: Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal reflux disease
Proton pump inhibitor
standard dose
Double dose
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: symptom improvement at 2 week after double dose rabeprazole treatment
timeFrame: Two weeks
Secondary outcomes:
measure: sustained symptom improvement at 6 week after treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae Paik Hospital, Inje University School of Medicine
Study officials:
affiliation: Internal Medicine, Haeundae Paik Hospital
name: Tae Oh Kim, M.D. PhD.
role: STUDY_DIRECTOR
affiliation: Internal Medicine, Haeundae Paik Hospital
name: Eun Hee Seo, M.D
role: PRINCIPAL_INVESTIGATOR
References: