Influence of Hygiene-Dietetic Habits and Treatment Adherence on the Effectiveness of the Gastroesophageal Reflux Illness Treatment With Rabeprazol.
Information source: Janssen-Cilag S.A., (formerly Janssen Sp)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Janssen-Cilag S.A., (formerly Janssen Sp) Official(s) and/or principal investigator(s):
Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial, Study Director, Affiliation: Janssen-Cilag S.A., (formerly Janssen Sp)
Summary
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.
Clinical Details
Official title: Influence of Hygiene-Dietetic Habits and Treatment Adherence on the Effectiveness of the Gastroesophageal Reflux Illness Treatment With Rabeprazol.
Study design: Natural History, Longitudinal, Defined Population, Prospective Study
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Influence of hygiene-dietetic habits and treatment adherence on the effectiveness of the gastroesophageal reflux illness treatment with Rabeprazol.
Ending date: November 2002
Last updated: August 2, 2007
|
