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

This study has been completed.
Sponsor:
Information provided by:
Janssen Cilag Pharmaceutica S.A.C.I., Greece
ClinicalTrials.gov Identifier:
NCT00216489
First received: September 13, 2005
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux
Heartburn
Drug: rabeprazole sodium
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Non Interventional Post Authorization Safety Study (PASS) On The Rabeprazole's Administration To Adults With Gastro-Oesophageal Reflux Disease (GORD)

Resource links provided by NLM:


Further study details as provided by Janssen Cilag Pharmaceutica S.A.C.I., Greece:

Primary Outcome Measures:
  • Incidence of adverse events throughout treatment (8 weeks) and follow up (12 months)

Secondary Outcome Measures:
  • Severity of symptoms at baseline and specified intervals during treatment and follow up, rated from "no problem" to "very severe problem"; physical examination and laboratory tests at end of treatment and after 4 months

Enrollment: 191
Study Start Date: March 2003
Study Completion Date: November 2005
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 disease (GERD) can be described as a condition with clearly identified clinical symptoms or the change in tissue structure that results from the reflux of contents from the stomach or small intestine into the esophagus. This is a study to confirm the safety and effectiveness of rabeprazole in the treatment of patients with GERD in routine primary health care. The study has two phases. Patients will receive treatment with rabeprazole tablets once daily for 8 weeks. In the second phase, patients will be monitored by their physician for a follow up period to end of study (12 months). Safety assessments include the incidence of adverse events throughout the treatment and follow up phases, and physical examination and laboratory tests at end of treatment and after 4 months. Assessments of effectiveness include the degree of relief of symptoms at beginning and end of treatment and at specific intervals during follow up. The study hypothesis is that rabeprazole is well-tolerated with long term treatment of patients with GERD in routine primary health care. Rabeprazole tablet (20 milligrams[mg]) once daily in the morning for 8 weeks. Dose may be increased to 2 tablets daily (40 mg maximum) at investigator's discretion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00216489

Sponsors and Collaborators
Janssen Cilag Pharmaceutica S.A.C.I., Greece
Investigators
Study Director: Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial Janssen-Cilag Pharmaceutica S.A.C.I.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00216489     History of Changes
Other Study ID Numbers: CR003502
Study First Received: September 13, 2005
Last Updated: April 22, 2010
Health Authority: Greece: Hellenic Republic Ministry Of Health And Welfare National Organization For Medicines

Keywords provided by Janssen Cilag Pharmaceutica S.A.C.I., Greece:
gastroesophageal reflux
heartburn
rabeprazole
GERD
anti-ulcer agents
proton pump inhibitor

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

ClinicalTrials.gov processed this record on July 20, 2014