German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00567021

Enrollment

67130

Registered

2007-12-04

Start date

2005-09-30

Completion date

2005-12-31

Last updated

2008-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Keywords

reflux, NSAR treatment, Patients with reflux symptoms or gastrointestinal symptoms after NSAR Treatment

Brief summary

This PMS study had the objective to evaluate under ordinary medical care conditions the efficacy and tolerability of esomeprazole in patients who where treated by general practitioners and internists.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with GERD, or NSAID related ulcers, who need treatment with esomeprazole.

Exclusion criteria

* Limitations; possible risks; warnings; contraindications mentioned in the SPC.

Design outcomes

Primary

Measure	Time frame
To gain further insight into the efficacy of esomeprazole under ordinary medical care conditions in consideration of diagnosis and type of NSAID therapy (if administered).	By estimating the proportion of treated subjects without any gastrointestinal symptoms at the end of the observational period 2. by assessing the change in intensity of gastrointestinal symptoms.

Secondary

Measure	Time frame
To get further insight into the details of the use, dosage scheme and duration of treatment with esomeprazole in this population	—

Outcome results