Dyspepsia, Gastrointestinal Disease, Signs and Symptoms, Digestive
Conditions
Brief summary
The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms resolution at the end of a subsequent treatment period of 7 weeks.
Interventions
DRUGEsomeprazole
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* At least 3 months of symptoms of pain or burning centered in the upper abdomen prior to enrollment. * Helicobacter pylori test performed at enrollment must be negative (Helicobacter pylori is a bacterial infection of the stomach).
Exclusion criteria
* Patients with symptoms of other gastrointestinal diseases, such as Gastroesophageal Reflux Disease (GERD), Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD). * Helicobacter pylori eradication treatment during the last 12 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is whether the patient is a responder or not after 8 weeks treatment. | — |
| The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary. | — |
| The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks, | — |
| The average symptom score and the percentage of symptom-free days during the 7-week treatment period, | — |
| Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy | — |
Countries
Austria, Belgium, Canada, Finland, France, Germany, Hungary, Mexico, Norway, South Africa, Sweden, Switzerland, United Kingdom
Outcome results
None listed