Influence of Hygiene-dietetic Habits and Treatment Adherence on the Effectiveness of the Gastroesophageal Reflux Illness Treatment With Rabeprazol

Gastroesophageal Reflux Clinical Trial

Official title:

Influence of Hygiene-dietetic Habits and Treatment Adherence on the Effectiveness of the Gastroesophageal Reflux Illness Treatment With Rabeprazol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00511966
• Other study ID #: CR009241
• Status: Terminated
• Phase: N/A
• First received: August 2, 2007
• Last updated: May 18, 2011
• Est. completion date: November 2002

Study information

• Verified date: April 2010
• Source: Janssen-Cilag, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Drug Agency
• Study type: Observational

Clinical Trial Summary

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.

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 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1049
• Est. completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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-Inflammatories) more than 3 days/week

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Other:
• Non-Pharmacologic Treatment
Non-Pharmacologic Treatment

Drug:
• Rabeprazole
As prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag, S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastroesophageal Reflux symptoms		8 weeks	No
Secondary	No secondary outcome measures			No

External Links

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