| June 20, 2006 |
| January 11, 2008 |
| August 2006 |
| September 2007 (final data collection date for primary outcome measure) |
- 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.
|
| Same as current |
| Complete list of historical versions of study NCT00343161 on ClinicalTrials.gov Archive Site |
- 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
|
- 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 in
- 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
|
| |
| Symptom Adapted Therapy in GERD Patients |
| 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 |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Gastroesophageal Reflux Disease (GERD). |
- Drug: esomeprazole
- Drug: Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)
|
| |
| |
| |
| Completed |
| 441 |
| October 2007 |
| September 2007 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 55 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Germany |
| |
| NCT00343161 |
|
| D9612L00109, SYMPATHY, EudraCT-No. 2006-001316-76 |
| AstraZeneca |
|
| Study Director: |
Michael Höcker, MD |
AstraZeneca Germany |
|
| Principal Investigator: |
Joachim Labenz, MD |
Evan. Jung-Stilling-Krankenhaus, Siegen, Germany |
|
|
| AstraZeneca |
| January 2008 |
