Symptom Adapted Therapy in GERD Patients (SYMPATHY)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00343161
First received: June 20, 2006
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 441
Study Start Date: August 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00343161     History of Changes
Other Study ID Numbers: D9612L00109, SYMPATHY, EudraCT-No. 2006-001316-76
Study First Received: June 20, 2006
Last Updated: January 21, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
Nexium

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

ClinicalTrials.gov processed this record on October 19, 2014