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

This study has been terminated.
(Due to the achievement of minimum required sample size and new changes in local regulations.)
Sponsor:
Information provided by:
Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier:
NCT00511966
First received: August 2, 2007
Last updated: May 18, 2011
Last verified: April 2010
History of Changes
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Hygiene-dietetic Habits and Treatment Adherence on the Effectiveness of the Gastroesophageal Reflux Illness Treatment With Rabeprazol

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by Janssen-Cilag, S.A.:

Primary Outcome Measures:
  • Gastroesophageal Reflux symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • No secondary outcome measures [ Designated as safety issue: No ]

Enrollment: 1049
Study Completion Date: November 2002
Groups/Cohorts Assigned Interventions
001 Drug: Rabeprazole
As prescribed
002 Other: Non-Pharmacologic Treatment
Non-Pharmacologic Treatment

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 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
Study Population

Patients with Gastroesophageal Reflux and symptomatic.

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-Inflammatories) more than 3 days/week
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511966

Sponsors and Collaborators
Janssen-Cilag, S.A.
Investigators
Study Director: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Janssen-Cilag, S.A.
  More Information

Additional Information:
Influence of hygiene-dietetic habits and treatment adherence on the effectiveness of the gastroesophageal reflux illness treatment with Rabeprazol.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Country Medical Director, Janssen-Cilag S.A., Spain
ClinicalTrials.gov Identifier: NCT00511966     History of Changes
Other Study ID Numbers: CR009241
Study First Received: August 2, 2007
Last Updated: May 18, 2011
Health Authority: Spain: Spanish Drug Agency

Keywords provided by Janssen-Cilag, S.A.:
Gastroesophageal Reflux
Rabeprazole

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

ClinicalTrials.gov processed this record on May 21, 2013