- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00511966
Influence of Hygiene-dietetic Habits and Treatment Adherence on the Effectiveness of the Gastroesophageal Reflux Illness Treatment With Rabeprazol
May 18, 2011 updated by: Janssen-Cilag, S.A.
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.
Study Overview
Status
Terminated
Conditions
Intervention / 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
Study Type
Observational
Enrollment (Actual)
1049
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Gastroesophageal Reflux and symptomatic.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
001
|
As prescribed
|
002
|
Non-Pharmacologic Treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gastroesophageal Reflux symptoms
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
---|
No secondary outcome measures
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion (Actual)
November 1, 2002
Study Registration Dates
First Submitted
August 2, 2007
First Submitted That Met QC Criteria
August 2, 2007
First Posted (Estimate)
August 6, 2007
Study Record Updates
Last Update Posted (Estimate)
May 19, 2011
Last Update Submitted That Met QC Criteria
May 18, 2011
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophagitis
- Peptic Ulcer
- Duodenal Diseases
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Rabeprazole
Other Study ID Numbers
- CR009241
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Rabeprazole
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Janssen Research & Development, LLCEisai Inc.CompletedGastroesophageal Reflux Disease (GERD)United States, Poland, United Kingdom, Belgium, Brazil
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Eisai Co., Ltd.Completed
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Yungjin Pharm. Co., Ltd.Seoul National University HospitalCompletedGastroesophageal Reflux DiseaseKorea, Republic of
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Seoul National University HospitalIlDong Pharmaceutical Co LtdCompletedEsophageal DiseaseKorea, Republic of
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Eisai Inc.CompletedSymptomatic Gastroesophageal Reflux Disease (sGERD)United States