Phase 2
Completed N=244
Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
Gastroesophageal Reflux Disease (GERD)
Source: ClinicalTrials.gov NCT00394472 ↗
Enrolled (actual)
244
Serious AEs
—
Results posted
Mar 2013
Primary outcomePrimary: Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment — 17; 8 Participants
Summary
The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients with an incomplete response to PPI treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Most One Day With Not More Than Mild Intensity of the Symptoms 'a Burning Feeling Behind the Breastbone' and 'Unpleasant Movement of Material Upwards From the Stomach' During the Last Seven Days of Treatment |
17; 8 | — |
| SECONDARY Plasma Concentration (µmol/L) of AZD3355 Analysed From Blood Sample Taken in the Interval One to Two Hours After the First Intake of AZD3355 65 mg Capsule |
0.96 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of written informed consent
- At least 6 months history of Gastroesophageal reflux disease (GERD) symptoms
- Continuous treatment with Proton Pump Inhibitor (PPI)
- Ability to read and write
Exclusion Criteria
- Prior surgery of the upper gastrointestinal (GI) tract
- History of clinically significant diseases other than GERD
- Need for concomitant medication with drugs that may influence gastrointestinal symptoms
Data sourced from ClinicalTrials.gov (NCT00394472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.