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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: December 3, 2007
Last updated: January 28, 2008
Last verified: January 2008
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.

Gastroesophageal Reflux

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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). [ Time Frame: 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 Outcome Measures:
  • To get further insight into the details of the use, dosage scheme and duration of treatment with esomeprazole in this population

Enrollment: 67130
Study Start Date: September 2005
Study Completion Date: December 2005
patients with GERD or NSAID-related ulcers


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Study Population
PC and internist

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00567021

Sponsors and Collaborators
Study Director: Kai Richter, MD AstraZeneca Medical Department
  More Information

No publications provided

Responsible Party: Dr. Kai Ritcher, AstraZeneca Germany Identifier: NCT00567021     History of Changes
Other Study ID Numbers: 1312004007, German PMS trial no.7
Study First Received: December 3, 2007
Last Updated: January 28, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
NSAR treatment
Patients with reflux symptoms or gastrointestinal symptoms after NSAR Treatment

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases processed this record on November 24, 2015