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)

CompletadoFase 3ClinicalTrials.gov

ID: NCT00658528Tipo: INTERVENTIONALInicio: 1 de feb de 2008Fin estimado: 1 de ene de 2010

Traducción no disponible, mostrando original

Resumen

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).

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Male or female, ages 18 to 75 years.
History of 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 C or D 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.

Criterios de exclusión

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).

Intervenciones

drug

Rabeprazole sodium

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

drug

Esomeprazole

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

Ubicaciones

Isidro Casanova, La Matanza, BUE, Argentina

Ramos Mejía, BUE, Argentina

San Isidro, BUE, Argentina

Capital Federal, CBA, Argentina

Mendoza, MEN, Argentina

Rosario, SFE, Argentina

San Juan, SJN, Argentina

Patrocinadores

PrincipalEisai Inc.

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