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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

August 2, 2007
May 18, 2011
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Gastroesophageal Reflux symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00511966 on ClinicalTrials.gov Archive Site
No secondary outcome measures [ Designated as safety issue: No ]
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Influence of Hygiene-dietetic Habits and Treatment Adherence on the Effectiveness of the Gastroesophageal Reflux Illness Treatment With Rabeprazol
Influence of Hygiene-dietetic Habits and Treatment Adherence on the Effectiveness of the Gastroesophageal Reflux Illness Treatment With Rabeprazol

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with Gastroesophageal Reflux and symptomatic.

Gastroesophageal Reflux
  • Other: Non-Pharmacologic Treatment
    Non-Pharmacologic Treatment
  • Drug: Rabeprazole
    As prescribed
  • 001
    Intervention: Drug: Rabeprazole
  • 002
    Intervention: Other: Non-Pharmacologic Treatment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1049
November 2002
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00511966
CR009241
No
Country Medical Director, Janssen-Cilag S.A., Spain
Janssen-Cilag, S.A.
Not Provided
Study Director: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Janssen-Cilag, S.A.
Janssen-Cilag, S.A.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP