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Symptom Adapted Therapy in GERD Patients (SYMPATHY)

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ClinicalTrials.gov Identifier: NCT00343161
Recruitment Status : Completed
First Posted : June 22, 2006
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The purpose of the study is to determine whether a maintenance treatment over 12 weeks with esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: esomeprazole Drug: Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate) Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 441 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open, Parallel-group, Multi-national, Multi-centre, Phase IV Study to Evaluate the Efficacy of Three Different Patient Management Strategies With and Without Esomeprazole 20 mg During a 3 Months Maintenance Phase Following an Initial 4-weeks Acute Treatment Phase in Subjects With Symptoms Thought to be GERD Related
Study Start Date : August 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources




Primary Outcome Measures :
  1. To compare the efficacy of three different long-term treatment strategies in primary care setting
  2. To compare treatments separately within different levels of symptom load according to clinical judgement at baseline
  3. Number of 'treatment failures' used as primary outcome variable.

Secondary Outcome Measures :
  1. To evaluate whether the Reflux Disease Questionnaire (RDQ)used in primary care setting adds value to clinical judgement in assessing baseline symptom load
  2. Evaluate whether the RDQ facilitates the decision on appropriate acute and maintenance treatment strategy
  3. To assess the additional impact of a concomitant low dose acetylsalicylic acid (ASA) therapy during acute and maintenance phase with regard to efficacy
  4. To evaluate whether there is a difference between treatment strategies with regard to patient satisfaction during maintenance phase using the GERD Impact Scale


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Patients who seek medical advice in primary care for symptoms thought to be GERD-related

Exclusion Criteria:

  • Clinical GERD diagnosis/treatment within last 3 month
  • History of severe esophagitis (i.e. LA grade C or D)
  • Previous anti-reflux surgery
  • History of drug abuse
  • Female patients who are pregnant or lactating or at risk of pregnancy

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): NCT00343161


  Show 96 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Michael Höcker, MD AstraZeneca Germany
Principal Investigator: Joachim Labenz, MD Evan. Jung-Stilling-Krankenhaus, Siegen, Germany

ClinicalTrials.gov Identifier: NCT00343161     History of Changes
Other Study ID Numbers: D9612L00109
SYMPATHY
EudraCT-No. 2006-001316-76
First Posted: June 22, 2006    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Nexium

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esomeprazole
Magnesium trisilicate
Aluminum Hydroxide
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antacids