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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567021
• Other study ID #: 1312004007
• Secondary ID: German PMS trial
• Status: Completed
• Phase: N/A
• First received: December 3, 2007
• Last updated: January 28, 2008
• Start date: September 2005
• Est. completion date: December 2005

Study information

• Verified date: January 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67130
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To get further insight into the details of the use, dosage scheme and duration of treatment with esomeprazole in this population