Phase 4
Completed N=108
To Assess the Efficacy of Esomeprazole 20mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole
Gastroesophageal Reflux Disease · GERD · Reflux Esophagitis
Source: ClinicalTrials.gov NCT01397084 ↗
Enrolled (actual)
108
Serious AEs
1.9%
Results posted
Feb 2013
Primary outcomePrimary: Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1). — -3.0 Days with heartburn — p=<0.001
Summary
Administration of esomeprazole 20 mg to subjects who still had heartburn after receiving rabeprazole 10 mg once daily for at least 4 weeks will result in statistically significant improvement of heartburn after 8-week treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1). |
-3.0 | <0.001 sig |
| SECONDARY Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1). |
-2.4 | — |
| SECONDARY Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). |
76; 24; 1 | — |
| SECONDARY Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). |
84; 18; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Male of female aged 20 years or more
- History of reflux esophagitis
- Ongoing (until date of Visit 1) treatment with rabeprazole 10 mg, given once daily, for at least 4 weeks.The subject must take rabeprazole at least 4 days a week in the past 7 days prior to Visit 1.
- Persisting symptoms of heartburn experienced at least 2 days during the past 7 days prior to Visit 1.
Exclusion Criteria
- Use of other PPIs and/or H2RA during rabeprazole treatment
- History or having other gastrointestinal diseases
- History of upper gastrointestinal surgery
- Initiation of medications that can affect digestive functions within 4 weeks before study treatment
- Inability to complete questionnaires
Data sourced from ClinicalTrials.gov (NCT01397084). 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.