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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00658528
First received: April 9, 2008
Last updated: June 30, 2014
Last verified: March 2010
  Purpose

The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).


Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
Drug: Rabeprazole sodium
Drug: Esomeprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Upper GI endoscopy (EGD), symptoms based on subject's daily diary and Investigator's assessment. [ Time Frame: Every 4-8 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events, Electrocardiograms (ECGs), laboratory evaluations (hematology, blood chemistry, urinalysis, serum gastrin), physical examinations, vital signs. [ Time Frame: Every 4-8 weeks. ] [ Designated as safety issue: Yes ]

Enrollment: 1060
Study Start Date: February 2008
Study Completion Date: January 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Rabeprazole sodium
Rabeprazole ER 50 mg capsule, taken orally, once daily for 4-8 weeks.
Other Name: Aciphex
Active Comparator: 2 Drug: Esomeprazole
Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks.

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 ER 50 mg or Esomeprazole 40 mg for the treatment of moderate to severe erosive GERD.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

KEY INCLUSION CRITERIA:

  1. Male or female, ages 18 to 75 years.
  2. History of 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 C or D 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658528

  Hide Study Locations
Locations
United States, California
Anaheim, California, United States, 92801
Argentina
Isidro Casanova, La Matanza, BUE, Argentina, 1765
Ramos Mejia, BUE, Argentina, 1221
San Isidro, BUE, Argentina, B1642BHH
Capital Federal, CBA, Argentina, C1425DND
Mendoza, MEN, Argentina, 5500
Rosario, SFE, Argentina, S2000BLG
Rosario, SFE, Argentina, S2000CRF
Rosario, SFE, Argentina, S2000CVB
San Juan, SJN, Argentina, 5447
Australia, New South Wales
Five Dock, New South Wales, Australia, 2046
Australia, Queensland
Carina Heights, Queensland, Australia, 4152
Kippa Ring, Queensland, Australia, 4021
Australia, Victoria
Box Hill, Victoria, Australia, 3128
Frankston, Victoria, Australia, 3199
Malvern, Victoria, Australia, 3144
Bulgaria
Plovdiv, Bulgaria, 4000
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1407
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1709
Stara Zagora, Bulgaria, 6000
Varna, Bulgaria, 9010
Canada, New Brunswick
Saint John, New Brunswick, Canada, E2K 1J5
Canada, Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada, A1A 3R5
Canada, Ontario
Guelph, Ontario, Canada, N1H 3R3
Hamilton, Ontario, Canada, L8N 3Z5
Newmarket, Ontario, Canada, L3Y 5G8
Toronto, Ontario, Canada, M6H 3M1
Windsor, Ontario, Canada, N8W 1E6
Canada, Quebec
Montreal, Quebec, Canada, H1T 2M4
Montreal, Quebec, Canada, H3A 1A1
Pointe-Claire, Quebec, Canada, H9R 3J1
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7K 1J5
Canada
Quebec, Canada, G1R 2J6
Quebec, Canada, G1L 3L5
Chile
Santiago, Chile
Vioa del Mar, Chile
Croatia
Rijeka, Croatia, 51 000
Zagreb, Croatia, 10 000
Estonia
Tartu, Estonia, 51014
France
Dieppe 76, France, 76200
La Chaussee St. Victor 41, France, 41260
Lyon Cedex 369, France, 69437
Marseille 13, France, 13009
Nice Cedex 36, France, 6100
Germany
Berlin, BE, Germany, 10967
Berlin, BE, Germany, 13509
Mannheim, BW, Germany, 68167
Muenchen, BY, Germany, 81669
Dietzenbach, HE, Germany, 63128
Marburg, HE, Germany, 35033
Wiesbaden, HE, Germany, 65185
Hamburg, HH, Germany, 22143
Dortmund, NW, Germany, 44137
Lienen/Kattenve nne, NW, Germany, 49536
Muenster, NW, Germany, 48159
Hungary
Budapest, Hungary, 1036
Dunaujvaros, Hungary, 2400
Kisber, Hungary, 2870
Miskolc, Hungary, 3530
Nagykanizsa, Hungary, 8800
Nyiregyhaza, Hungary, 4400
Szentes, Hungary, 6600
Veszprem, Hungary, 8200
Zalaegerszeg, Hungary, 8900
India
New Delhi, Delhi, India, 110017
New Delhi, Delhi, India, 110 060
New Delhi, Delhi, India, 110002
Ahmedabad, Gujarat, India, 380006
Manipal, Karnataka, India, 576104
Bhopal, Madhya Pradesh, India, 462038
Aurangabad, Maharashtra, India, 431005
Mumbai, Maharashtra, India, 400 022
Mumbai, Maharashtra, India, 400012
Mumbai, Maharashtra, India, 400016
Mumbai, Maharashtra, India, 400020
Nagpur, Maharashtra, India, 440012
Pune, Maharashtra, India, 411001
Pune, Maharashtra, India, 411004
Pune, Maharashtra, India, PUNE-411013
Thane, Maharashtra, India, 400001
Ludhiana, Punjab, India, 141008
Jaipur, Rajasthan, India, 302001
Jaipur, Rajasthan, India, 302004
Lucknow, Uttar Pradesh, India, 226003
Latvia
Riga, Latvia, LV-1002
Riga, Latvia, LV-1005
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Yufang Lu, MD, PhD Eisai Inc.
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00658528     History of Changes
Other Study ID Numbers: E3810-G000-301, 2007-005570-32
Study First Received: April 9, 2008
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
GERD
erosive GERD
erosive esophagitis

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Esomeprazole
Rabeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014