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

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ClinicalTrials.gov Identifier: NCT00567021
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : January 29, 2008
Sponsor:
Information provided by:
AstraZeneca

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

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
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Group/Cohort
1
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

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Study Population
PC and internist
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00567021


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

Responsible Party: Dr. Kai Ritcher, AstraZeneca Germany
ClinicalTrials.gov Identifier: NCT00567021     History of Changes
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:
reflux
NSAR treatment
Patients with reflux symptoms or gastrointestinal symptoms after NSAR Treatment

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases