Phase 4
Completed N=337
A Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)
Source: ClinicalTrials.gov NCT00734097 ↗Enrolled (actual)
337
Serious AEs
1.3%
Results posted
Oct 2012
Primary outcomePrimary: Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment — -3.44 Days per week with symptoms
Summary
The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment |
-3.44 | — |
| SECONDARY Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment |
-3.08 | — |
| SECONDARY Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment |
-1.56 | — |
| SECONDARY Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment |
-1.34 | — |
| SECONDARY Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment. |
-2.95 | — |
| SECONDARY Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment. |
-3.28 | — |
| SECONDARY Change in Frequency of Epigastric Pain After 4 Weeks of Treatment |
-2.77 | — |
| SECONDARY Change in Frequency of Epigastric Pain After 8 Weeks of Treatment |
-3.16 | — |
| SECONDARY Change in Severity of Epigastric Pain After 8 Weeks of Treatment |
-1.34 | — |
| SECONDARY Change in Severity of Epigastric Pain After 4 Weeks of Treatment |
-1.17 | — |
| SECONDARY Change in Severity of Acid Regurgitation After 8 Weeks of Treatment |
-1.51 | — |
| SECONDARY Change in Severity of Acid Regurgitation After 4 Weeks of Treatment |
-1.31 | — |
Eligibility Criteria
Inclusion Criteria
- Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
- informed consent
- over 18 years of age
Exclusion Criteria
- Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study
- More than 1 other course of PPI treatment in the previous 12 month
- previous use of esomeprazole
- presence of alarm symptoms
Data sourced from ClinicalTrials.gov (NCT00734097). 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.