Status:
COMPLETED
A Study of the Safety of Rabeprazole Administered to Adults With Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
Janssen Cilag Pharmaceutica S.A.C.I., Greece
Conditions:
Gastroesophageal Reflux
Heartburn
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to confirm the safety and effectiveness of rabeprazole in the treatment of patients with erosive or ulcerative gastroesophageal reflux disease (GERD) in routine primary hea...
Detailed Description
Gastroesophageal reflux can result in mild to severe symptoms in some persons. Heartburn, a burning sensation or discomfort rising behind the breastbone, is a common symptom. Gastroesophageal reflux d...
Eligibility Criteria
Inclusion
- Patients with symptoms of erosive or ulcerative gastroesophageal reflux disease (GERD) during at least a period of 3 months prior to study initiation and symptoms of GERD for at least 3 days per week within the 2 weeks prior to study initiation. The symptoms of erosive or ulcerative gastroesophageal reflux disease includes the following: heartburn, aching behind the breastbone, a need for antacids, and difficulty in swallowing. Patients with evidence by endoscopy of erosive or ulcerative gastroesophageal reflux disease with no Barret-type tissue transformation.
Exclusion
- No narrowing or inflammation of the esophagus
- no known gastro-duodenal ulcer
- no infections (other than H. Pylori), inflammations or hemorrhage of the stomach, small or large intestine
- no prior surgery of the stomach or intestine
- no known history of primary kinetic disorders of the esophagus, other than GERD
- no history of enlarged veins of the esophagus or stomach
- no pregnant or nursing females, or those lacking adequate contraception.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT00216489
Start Date
March 1 2003
End Date
November 1 2005
Last Update
April 26 2010
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