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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00567021
First received: December 3, 2007
Last updated: January 28, 2008
Last verified: January 2008
History of Changes
  Purpose

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
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:

MedlinePlus related topics: GERD
U.S. FDA Resources

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
Groups/Cohorts
1
patients with GERD or NSAID-related ulcers

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567021

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

No publications provided

Responsible Party: Dr. Kai Ritcher, AstraZeneca Germany
ClinicalTrials.gov 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:
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

ClinicalTrials.gov processed this record on May 23, 2013