Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)

A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive gastroesophageal reflux disease (eGERD).

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease (GERD)
• Intervention / Treatment: Drug: Rabeprazole sodium; Drug: Esomeprazole

Detailed Description

This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of mild to moderate erosive Gastroesophageal Reflux Disease (GERD).

• Study Type: Interventional
• Enrollment (Actual): 1397
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
  • Arizona
    • Tucson, Arizona, United States, 85712
    • Tucson, Arizona, United States, 85741
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
    • Sherwood, Arkansas, United States, 72120
  • California
    • Anaheim, California, United States, 92801
    • Chula Vista, California, United States, 91910
    • Fullerton, California, United States, 92835
    • Irvine, California, United States, 92618
    • Laguna Hills, California, United States, 92653
    • Mission Hills, California, United States, 91345
    • Redwood, California, United States, 94062
    • San Diego, California, United States, 92123
    • San Louis Obispo, California, United States, 93405
    • West Covina, California, United States, 91790
  • Colorado
    • Pueblo, Colorado, United States, 81008
    • Wheat Ridge, Colorado, United States, 80033
  • Connecticut
    • Bristol, Connecticut, United States, 6010
    • Hartford, Connecticut, United States, 6102
  • Florida
    • Boynton Beach, Florida, United States, 33426
    • Hialeah, Florida, United States, 33010
    • Hollywood, Florida, United States, 33021
    • Jacksonville, Florida, United States, 32256
    • Jupiter, Florida, United States, 33458
    • Largo, Florida, United States, 33777
    • Lauderdale Lakes, Florida, United States, 33319
    • Naples, Florida, United States, 34102
    • Orlando, Florida, United States, 32806
    • Tampa, Florida, United States, 33613
    • Tampa, Florida, United States, 33607
    • Tampa, Florida, United States, 33618
  • Georgia
    • Newnan, Georgia, United States, 30263
  • Illinois
    • Rockford, Illinois, United States, 61107
  • Iowa
    • Clive, Iowa, United States, 50325
  • Kansas
    • Kansas City, Kansas, United States, 66160
    • Topeka, Kansas, United States, 66606
  • Kentucky
    • Louisville, Kentucky, United States, 40202
    • Louisville, Kentucky, United States, 40291
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
    • Slidell, Louisiana, United States, 70458
  • Maryland
    • Annapolis, Maryland, United States, 21401
    • Hagerstown, Maryland, United States, 21742
  • Missouri
    • Mexico, Missouri, United States, 65265
    • Washington, Missouri, United States, 63090
  • New Jersey
    • Vineland, New Jersey, United States, 8360
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
  • New York
    • Bayshore, New York, United States, 11706
    • Hartsdale, New York, United States, 10530
    • Mineola, New York, United States, 11501
    • New York, New York, United States, 10021
    • Pittsford, New York, United States, 14534
  • North Carolina
    • Boone, North Carolina, United States, 28607
    • Chapel Hill, North Carolina, United States, 27599
    • Charlotte, North Carolina, United States, 28209
    • Jacksonville, North Carolina, United States, 28546
    • New Bern, North Carolina, United States, 28562
    • Wilmington, North Carolina, United States, 28401
  • North Dakota
    • Fargo, North Dakota, United States, 58104
  • Ohio
    • Dayton, Ohio, United States, 45415
  • Oregon
    • Portland, Oregon, United States, 97210
    • Portland, Oregon, United States, 97225
    • Portland, Oregon, United States, 97220
  • South Carolina
    • Anderson, South Carolina, United States, 29621
    • Charleston, South Carolina, United States, 29414
    • Columbia, South Carolina, United States, 29203
  • Tennessee
    • Franklin, Tennessee, United States, 37067
    • Germantown, Tennessee, United States, 38138
    • Jackson, Tennessee, United States, 38301
    • Johnson City, Tennessee, United States, 37604
    • Kingsport, Tennessee, United States, 37660
    • Nashville, Tennessee, United States, 37203
    • Nashville, Tennessee, United States, 37211
  • Texas
    • Beaumont, Texas, United States, 77701
    • Bryan, Texas, United States, 77802
    • Dallas, Texas, United States, 75231
    • Fort Worth, Texas, United States, 76104
    • Houston, Texas, United States, 77079
    • San Antonio, Texas, United States, 78229
  • Virginia
    • Chesapeake, Virginia, United States, 23320
  • Washington
    • Bellevue, Washington, United States, 98004
    • Spokane, Washington, United States, 99216
    • Spokane, Washington, United States, 92204-2318
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
    • Milwaukee, Wisconsin, United States, 53209
    • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

KEY INCLUSION CRITERIA:

1. Male or female, ages 18 to 75 years.
2. History of gastroesophageal reflux disease (GERD) symptoms for at least 3 months immediately before screening.
3. Heartburn for at least 2 days a week for at least 1 month before screening.
4. Esophageal erosions of Los Angeles (LA) Grades A or B based on EGD taken within 14 days prior to enrollment.
5. Subjects who are H. pylori negative based on a screening test.
6. Females should be either of non-childbearing potential or of childbearing potential. Females of childbearing potential must have negative pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception.
7. Subjects must be able to read, write, and understand the language of the symptom diary.

KEY EXCLUSION CRITERIA:

1. Current or a history of esophageal motility disorders.
2. Current or a history of Barrett's esophagus. Current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications).
3. Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
4. Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.
5. Inflammatory bowel disease.
6. Unstable diabetes mellitus.
7. History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.
8. Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (>=20 mg/day prednisone or equivalent), or aspirin (> 325 mg/day).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Rabeprazole sodium; Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.; Other Names: Aciphex
Active Comparator: 2	Drug: Esomeprazole; Esomeprazole 40 mg capsule, once daily for 4-8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks	Healing at Week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade A or B from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Gread D: Mucosal breaks involving at least 75% of the esophageal circumference.	Baseline and Week 8
Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks	Healing at Week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade A or B from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Gread D: Mucosal breaks involving at least 75% of the esophageal circumference.	Baseline and Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4	During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days.	Week 4

Collaborators and Investigators

• Sponsor: Eisai Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: April 9, 2008
• First Submitted That Met QC Criteria: April 14, 2008
• First Posted (Estimate): April 15, 2008

Study Record Updates

• Last Update Posted (Estimate): May 4, 2016
• Last Update Submitted That Met QC Criteria: March 28, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: GERD; erosive esophagitis; erosive GERD
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole; Esomeprazole
• Other Study ID Numbers: E3810-G000-303