N/A
N=1,995
Efficacy of Pantoprazole in Patients Older Than 12 Years Who Have Symptoms of Non-Erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (eGERD)
Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT00561730 ↗Enrolled (actual)
1,995
Serious AEs
0.1%
Results posted
Sep 2010
Primary outcome: Primary: Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice) — 5.31; 4.60; 3.67; 2.95 Units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Pantoprazole (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Nycomed
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice) |
5.31; 4.60; 3.67; 2.95; 2.51; 2.14 | — |
| PRIMARY Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) |
6.14; 4.62; 3.34; 2.43; 1.94; 1.57 | — |
| PRIMARY Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) |
4.73; 3.66; 2.71; 2.11; 1.75; 1.49 | — |
| PRIMARY Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice) |
2.48; 2.12; 1.76; 1.52; 1.40; 1.27 | — |
| PRIMARY Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice) |
3.00; 2.38; 1.84; 1.51; 1.30; 1.13 | — |
| PRIMARY Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice) |
3.15; 2.62; 2.15; 1.85; 1.62; 1.49 | — |
| SECONDARY Physician's Assessment of Heartburn |
3.08; 1.35 | — |
| SECONDARY Physician's Assessment of Acid Eructation |
2.74; 1.25 | — |
| SECONDARY Physician's Assessment of Painful Swallowing |
1.72; 1.07 | — |
| SECONDARY Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit |
67.4; 25.0; 3.0; 0.7; 3.9 | — |
| SECONDARY Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit |
81.1; 14.0; 1.0; 0.1; 3.9 | — |
Summary
The aim of the study was to evaluate the effect of 7 days treatment with Pantoprazole 40 mg and 20 mg on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) in clinical practice. During the study, the patients had to complete a short version of a patient-orientated, self-assessed reflux questionnaire (ReQuest™ in Practice).
Eligibility Criteria
Main inclusion criteria:
- Outpatients with erosive gastro-esophageal reflux disease (eGERD according to Los Angeles classification grade A-D) or non-erosive reflux disease (NERD)
Main exclusion criteria:
- Criteria as defined in the Summary of Product Characteristics (Chapter 4.3)
Data sourced from ClinicalTrials.gov (NCT00561730). 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.