NCT00511966

Brief 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.

Trial Health

10
At Risk

Trial Health Score

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

Enrollment
1,049

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

Click on a node to explore related trials.

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 Reflux

Keywords

Gastroesophageal RefluxRabeprazole

Outcome Measures

Primary Outcomes (1)

  • Gastroesophageal Reflux symptoms

    8 weeks

Secondary Outcomes (1)

  • No secondary outcome measures

Study Arms (2)

001

Drug: Rabeprazole

002

Other: Non-Pharmacologic Treatment

Interventions

Non-Pharmacologic TreatmentOTHER

Non-Pharmacologic Treatment

002
RabeprazoleDRUG

As prescribed

001

Eligibility Criteria

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

Patients with Gastroesophageal Reflux and symptomatic.

You may qualify if:

  • Patients with Gastroesophageal pathology erosive or non-erosive and acute or chronic treated with Rabeprazol per clinical practice

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

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