NCT00511745

Brief Summary

The purpose of this study is to evaluate the safety of rabeprazole 20mg/day in polymedicated patients and to examine the necessity of adjusted dosage in both therapies (rabeprazole and concomitant drug). Proton pump inhibitors (PPI) act in the final step of the gastric secretion. PPI's block ATP-ase H+/K+ in gastric parietals cells. 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. In this context, the objective of the study is to evaluate the safety of rabeprazole as a concomitant treatment and examine the clinical practice the interaction with drugs whose absorption has gastric pH dependence.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,157

participants targeted

Target at P75+ for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
Last Updated

May 19, 2011

Status Verified

April 1, 2010

First QC Date

August 2, 2007

Last Update Submit

May 18, 2011

Conditions

Gastroesophageal RefluxGastric Ulcer

Keywords

InteractionsAdjusted dosesDuodenal UlcerGastric UlcerErosive or ulcerate Gastroesophageal RefluxRabeprazoleGastroesophageal reflux

Outcome Measures

Primary Outcomes (1)

  • Safety of rabeprazole 20mg/day in polymedicated patients

    2 or 8 weeks, as per investigator criteria

Secondary Outcomes (1)

  • No secondary outcome measures

Study Arms (1)

001

Drug: Rabeprazol

Interventions

RabeprazolDRUG

As prescribed

001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving rabeprazole and a concomitant drug (one or more) such a non-steroidal anti-inflammatory drugs (NSAID), benzodiazepines or corticoids

You may qualify if:

  • Patients receiving Rabeprazole and a concomitant drug (one or more) such a non-steroidal anti-inflammatory drugs (NSAID), benzodiazepines or corticoids

You may not qualify if:

  • Pregnant or lactating patients
  • Other severe concomitant pathologies
  • History or drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Gastroesophageal RefluxStomach UlcerDuodenal Ulcer

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPeptic UlcerDuodenal DiseasesIntestinal DiseasesStomach Diseases

Study Officials

  • Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial

    Janssen-Cilag, S.A.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 2, 2007

First Posted

August 6, 2007

Study Completion

November 1, 2002

Last Updated

May 19, 2011

Record last verified: 2010-04