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Completed

NCT Number: NCT00567021

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

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.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2005
Study completion
2005
First posted
Dec 4, 2007
Registry last updated
Jan 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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