Official Title: “Influence of Hygiene-Dietetic Habits and Treatment Adherence on the Effectiveness of the Gastroesophageal Reflux Illness Treatment With Rabeprazol.”

The objective of this study is to evaluate hygiene-dietetic habits as co-adjuvant treatment of the pharmacologic therapy use to treat the Gastroesophageal Reflux. The high effectiveness of the new pharmacologic treatment in Gastroesophageal Reflux pathology makes it necessary to review the role of hygiene-dietetic habits in this illness. Proton pump inhibitors (PPI) act in the final step of the gastric secretion. PPIs block ATP-ase H+/K+ in gastric parietals cells. This mechanism generates a higher acid inhibition and longer than the inhibition produced by H2-receptor antagonists. It has been described that inhibition of acid secretion has produced the recovery of the Gastroesophageal pathology in a high percentage of the patients resistant to conventional drugs. The primary objective is to evaluate hygiene-dietetic habits as co-adjuvant of Rabeprazol treatment in the treatment of Gastroesophageal Reflux. The secondary objective is to evaluate the safety of Rabeprazol in the treatment of Gastroesophageal Reflux under clinical practice.

Study Type: Observational

Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Gastroesophageal Reflux illness is a multifactor pathology with a common mechanism: a prolonged exposure of the esophageal mucosa to the gastric solutions. Modification of the life style and the hygiene-dietetic habits are frequently recommended as an initial therapeutic instrument in Gastroesophageal Reflux pathology. But there isn't an agreement about the effectiveness of these habits in the improvement of the illness. Different clinical practice guidances have shown contradictions in the effectiveness of changing hygiene-dietetics habits of the life style. The high effectiveness of the new pharmacologic treatment in Gastroesophageal Reflux pathology make necessary to review the role of hygiene-dietetic habits in this illness. Proton pump inhibitors (PPI) act in the final step of the gastric secretion. PPIs block ATP-ase H+/K+ in gastric parietals cells. This mechanism generates a higher acid inhibition and longer than the inhibition produced by H2-receptor antagonists. It has been described that inhibition of acid secretion has produced a recovery of the gastroesophageal pathology in a high percentage of the patients resistant to conventional drugs. This is an observational, multicenter, open and prospective study. The primary objective is to evaluate hygiene-dietetic habits as co-adjuvant of Rabeprazol treatment in the Gastroesophageal Reflux . It`s expected to include 570 patients with Gastroesophageal pathology erosive or non-erosive and acute or chronic treated with Rabeprazol per clinical practice, 20mg per day, orally, for 8 weeks. All data collected will be prospective and will include the following: demographic data, progress of the pathology, change of hygiene-dietetic habits, treatment adherence, concomitant treatments and adverse events.

Rabeprazol, 20mg per day, orally, for 8 weeks duration.

Inclusion Criteria:

• Patients with Gastroesophageal pathology erosive or non-erosive and acute or chronic treated with Rabeprazol per clinical practice

Exclusion Criteria:

• Patients pregnant or lactating
• Other gastrointestinal pathologies
• Intestinal or gastric survey
• Other severe concomitant pathologies
• Drug abuse or use of NSAIs (Non-Steroidal Anti-Inflamatories) more than 3 days/week

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Janssen-Cilag S.A., (formerly Janssen Sp)

Overall Clinical Trial Officials and Contacts

Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Study Director Janssen-Cilag S.A., (formerly Janssen Sp)  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00511966

Study ID Number: CR009241

ClinicalTrials.gov Identifier: NCT00511966

Health Authority: Spain: Spanish Drug Agency

Influence of hygiene-dietetic habits and treatment adherence on the effectiveness of the gastroesophageal reflux illness treatment with Rabeprazol.