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

NCT01391715 | Withdrawn Phase 3

• 1 other identifier: 01July2011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux disease; Proton pump inhibitor; standard dose; Double dose

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• sustained symptom improvement at 6 week after treatment

  6 weeks

Study Arms (2)

Double dose rabeprazole

ACTIVE COMPARATOR

Rabeprazole 20m bid per day will be given for 2 weeks

Drug: rabeprazole

standard dose rabeprazole

PLACEBO COMPARATOR

rabeprazole 20mg per day will bi given for 2 weeks

Drug: standard dose rabeprazole

Interventions

rabeprazole DRUG

rabeprazole 20mg bid per day for 2 weeks

Double dose rabeprazole

standard dose rabeprazole DRUG

rabeprazole 20mg qd per day for 2 weeks

standard dose rabeprazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inje University: lead

Study Sites (1)

Haeundae Paik Hospital, Inje University School of Medicine

Busan, 612-030, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tae Oh Kim, M.D. PhD.

  Internal Medicine, Haeundae Paik Hospital

  STUDY DIRECTOR

• Eun Hee Seo, M.D

  Internal Medicine, Haeundae Paik Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 12, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

KR (1)