A Study of the Safety of Rabeprazole Administered to Adults With Gastroesophageal Reflux Disease (GERD)

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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 health care.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Cilag Pharmaceutica S.A.C.I., Greece
• Treatments: Rabeprazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.