COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00567021
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : January 29, 2008
Information provided by:

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.

Condition or disease
Gastroesophageal Reflux

Layout table for study information
Study Type : Observational
Actual Enrollment : 67130 participants
Time Perspective: Prospective
Official Title: German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms
Study Start Date : September 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

patients with GERD or NSAID-related ulcers

Primary Outcome Measures :
  1. 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 :
  1. To get further insight into the details of the use, dosage scheme and duration of treatment with esomeprazole in this population

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00567021

Sponsors and Collaborators
Layout table for investigator information
Study Director: Kai Richter, MD AstraZeneca Medical Department
Layout table for additonal information
Responsible Party: Dr. Kai Ritcher, AstraZeneca Germany Identifier: NCT00567021    
Other Study ID Numbers: 1312004007
German PMS trial no.7
First Posted: December 4, 2007    Key Record Dates
Last Update Posted: January 29, 2008
Last Verified: January 2008
Keywords provided by AstraZeneca:
NSAR treatment
Patients with reflux symptoms or gastrointestinal symptoms after NSAR Treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases