Phase 2
Completed N=27
A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience
Source: ClinicalTrials.gov NCT01043185 ↗Enrolled (actual)
27
Serious AEs
0.9%
Results posted
Jun 2011
Primary outcomePrimary: Total Number of Reflux Episodes During 24 Hours — 59.4; 50.7; 44.3; 38.0 Episodes
Summary
The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Reflux Episodes During 24 Hours |
59.4; 50.7; 44.3; 38.0; 80.5 | — |
| SECONDARY Number of Acid Reflux Episodes |
9.6; 8.0; 6.2; 6.3; 14.7 | — |
| SECONDARY Number of Weakly Acidic Reflux Episodes |
37.0; 35.4; 28.7; 28.4; 51.6 | — |
| SECONDARY Number of Weakly Alkaline Reflux Episodes |
0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Provide informed consent
- History of GERD with persistent symptoms despite treatment with PPI
- Otherwise normal physical health
Exclusion Criteria
- History of GERD with symptoms that has not improved at all during treatment with PPI
- Prior surgery of the upper gastrointestinal tract
- History of significant heart disease, cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric or gastrointestinal disorders besides GERD
Data sourced from ClinicalTrials.gov (NCT01043185). 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.