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OpenTrials
Completed

NCT Number: NCT00768443

Symptoms and Management Strategies in Gastroesophageal Reflux Disease (GERD)

This a non-interventional multi-centre study to evaluate the symptom load and management strategies in PPI-treated GERD patients with persistent GERD symptoms..

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Bjelovar, Croatia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of informed consent
  • Subjects with a diagnosis of GERD and with predominant typical GERD symptoms: heartburn/regurgitation
  • Subjects who fail to obtain satisfactory symptomatic response after their first full course (4-8 weeks) of standard dose PPI (once a day)

Exclusion criteria

  • Inability to read and/or understand Patient Reported Outcomes questionnaires
  • Subjects where the only reason for the visit is renewing the prescription
  • A history of an incomplete response to PPI treatment prior to current course of treatment

Treatment and study plan

Primary outcomes

  1. To assess the symptom load and impact on daily life in PPI-treated GERD patients with persistent GERD symptoms

    Time frame: Once, at first visit

Secondary outcomes

  1. To describe the frequency and severity of extra-oesophageal and/or atypical GERD symptoms and to assess the concordance between patient-reported and physician-reported symptom load

    Time frame: Once, at first visit

  2. To describe current and previous treatment strategies and to describe the diagnostic and therapeutic approaches during the study visit

    Time frame: Once, at first visit

  3. To describe the impact of persistent GERD symptoms on work productivity

    Time frame: Once, at first visit

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Epidemiological Study to Assess the Symptom Patterns and Management Strategies in Patients Consulting With Persistent GERD Symptoms in Primary Care

Acronym: PHENIX

Important dates

Study start
2008
Study completion
2009
First posted
Oct 8, 2008
Registry last updated
Dec 7, 2010

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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