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

NCT00658632 | Completed Phase 3 Results

• 1 other identifier: E3810-G000-303
• Study Type: interventional
• Target: 1,397
• Locations: 1 country
• Sites: 85

Brief Summary

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).

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

GERD; erosive GERD; erosive esophagitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4

  Week 4

Study Arms (2)

1

EXPERIMENTAL

Drug: Rabeprazole sodium

2

ACTIVE COMPARATOR

Drug: Esomeprazole

Interventions

Rabeprazole sodium DRUG

Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.

Also known as: Aciphex

1

Esomeprazole DRUG

Esomeprazole 40 mg capsule, once daily for 4-8 weeks.

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ages 18 to 75 years.
• History of gastroesophageal reflux disease (GERD) symptoms for at least 3 months immediately before screening.
• Heartburn for at least 2 days a week for at least 1 month before screening.
• Esophageal erosions of Los Angeles (LA) Grades A or B based on EGD taken within 14 days prior to enrollment.
• Subjects who are H. pylori negative based on a screening test.
• 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.
• Subjects must be able to read, write, and understand the language of the symptom diary.

You may not qualify if:

• Current or a history of esophageal motility disorders.
• 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).
• Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.
• Current or a history of cancer, with the exception of fully excised skin basal cell carcinoma.
• Inflammatory bowel disease.
• Unstable diabetes mellitus.
• History of esophageal, gastric and duodenal surgery except simple suturing of an ulcer.
• Subjects who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (\>=20 mg/day prednisone or equivalent), or aspirin (\> 325 mg/day).

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (85)

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Huntsville, Alabama, 35801, United States

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Tucson, Arizona, 85712, United States

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Tucson, Arizona, 85741, United States

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Little Rock, Arkansas, 72205, United States

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Sherwood, Arkansas, 72120, United States

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Anaheim, California, 92801, United States

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Chula Vista, California, 91910, United States

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Fullerton, California, 92835, United States

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Irvine, California, 92618, United States

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Laguna Hills, California, 92653, United States

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Mission Hills, California, 91345, United States

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Redwood City, California, 94062, United States

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San Diego, California, 92123, United States

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San Louis Obispo, California, 93405, United States

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West Covina, California, 91790, United States

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Pueblo, Colorado, 81008, United States

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Wheat Ridge, Colorado, 80033, United States

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Bristol, Connecticut, 6010, United States

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Hartford, Connecticut, 6102, United States

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Boynton Beach, Florida, 33426, United States

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Hialeah, Florida, 33010, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32256, United States

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Jupiter, Florida, 33458, United States

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Largo, Florida, 33777, United States

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Lauderdale Lakes, Florida, 33319, United States

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Naples, Florida, 34102, United States

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Orlando, Florida, 32806, United States

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Tampa, Florida, 33607, United States

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Tampa, Florida, 33613, United States

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Tampa, Florida, 33618, United States

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Newnan, Georgia, 30263, United States

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Rockford, Illinois, 61107, United States

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Clive, Iowa, 50325, United States

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Kansas City, Kansas, 66160, United States

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Topeka, Kansas, 66606, United States

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Louisville, Kentucky, 40202, United States

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Louisville, Kentucky, 40291, United States

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Baton Rouge, Louisiana, 70809, United States

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Slidell, Louisiana, 70458, United States

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Annapolis, Maryland, 21401, United States

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Hagerstown, Maryland, 21742, United States

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Mexico, Missouri, 65265, United States

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Washington, Missouri, 63090, United States

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Vineland, New Jersey, 8360, United States

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Albuquerque, New Mexico, 87106, United States

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Bay Shore, New York, 11706, United States

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Hartsdale, New York, 10530, United States

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Mineola, New York, 11501, United States

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New York, New York, 10021, United States

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Pittsford, New York, 14534, United States

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Boone, North Carolina, 28607, United States

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Chapel Hill, North Carolina, 27599, United States

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Charlotte, North Carolina, 28209, United States

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Jacksonville, North Carolina, 28546, United States

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New Bern, North Carolina, 28562, United States

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Wilmington, North Carolina, 28401, United States

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Fargo, North Dakota, 58104, United States

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Dayton, Ohio, 45415, United States

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Portland, Oregon, 97210, United States

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Portland, Oregon, 97220, United States

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Portland, Oregon, 97225, United States

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Anderson, South Carolina, 29621, United States

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Charleston, South Carolina, 29414, United States

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Columbia, South Carolina, 29203, United States

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Franklin, Tennessee, 37067, United States

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Germantown, Tennessee, 38138, United States

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Jackson, Tennessee, 38301, United States

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Johnson City, Tennessee, 37604, United States

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Kingsport, Tennessee, 37660, United States

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Nashville, Tennessee, 37203, United States

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Nashville, Tennessee, 37211, United States

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Beaumont, Texas, 77701, United States

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Bryan, Texas, 77802, United States

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Dallas, Texas, 75231, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77079, United States

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San Antonio, Texas, 78229, United States

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Chesapeake, Virginia, 23320, United States

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Bellevue, Washington, 98004, United States

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Spokane, Washington, 92204-2318, United States

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Spokane, Washington, 99216, United States

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Madison, Wisconsin, 53715, United States

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Milwaukee, Wisconsin, 53209, United States

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Milwaukee, Wisconsin, 53215, United States

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MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole; Esomeprazole

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; Omeprazole

Results Point of Contact

• Title: Eisai Medical Services
• Organization: Eisai Inc.

888-422-4743

Study Officials

• Yufang Lu

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 15, 2008
• Study Start: February 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 4, 2016
• Results First Posted: June 23, 2015

Record last verified: 2016-03

Locations

US (85)