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| Sponsor: | Janssen-Cilag S.A., (formerly Janssen Sp) |
|---|---|
| Information provided by: | Janssen-Cilag S.A., (formerly Janssen Sp) |
| ClinicalTrials.gov Identifier: | NCT00511966 |
Purpose
The objective of this Observational study is to evaluate hygiene-dietetic habits as co-adjuvant treatment of the pharmacologic therapy use to treat Gastroesophageal Reflux.
| Condition | Intervention |
|---|---|
|
Gastroesophageal Reflux |
Other: Non-Pharmacologic Treatment Drug: Rabeprazole |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Influence of Hygiene-dietetic Habits and Treatment Adherence on the Effectiveness of the Gastroesophageal Reflux Illness Treatment With Rabeprazol |
| Enrollment: | 1049 |
| Study Completion Date: | November 2002 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 001 |
Drug: Rabeprazole
As prescribed
|
| 002 |
Other: Non-Pharmacologic Treatment
Non-Pharmacologic Treatment
|
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 is not 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 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. PPI's block ATP-ase H+/K+ in gastric parietals cells. This mechanism generates a higher acid inhibition, 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 Gastroesophageal Reflux . It is 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. Observational Study - No investigational drug administered
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with Gastroesophageal Reflux and symptomatic.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Janssen-Cilag S.A., Spain ( Country Medical Director ) |
| Study ID Numbers: | CR009241 |
| Study First Received: | August 2, 2007 |
| Last Updated: | November 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00511966 History of Changes |
| Health Authority: | Spain: Spanish Drug Agency |
|
Gastroesophageal Reflux Rabeprazole |
|
Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Gastrointestinal Agents Enzyme Inhibitors Gastroesophageal Reflux Pharmacologic Actions Esophageal Motility Disorders |
Deglutition Disorders Digestive System Diseases Therapeutic Uses Anti-Ulcer Agents Esophageal Diseases Rabeprazole |