N/A
N=1,045
Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders
Sleep Disorders · Non-Erosive Reflux Disease · Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT00830115 ↗Enrolled (actual)
1,045
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcome: Primary: Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) — 2.94; 2.62; 2.28; 2.03 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
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) |
2.94; 2.62; 2.28; 2.03; 1.86; 1.74 | — |
| PRIMARY Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) |
3.65; 3.07; 2.53; 2.21; 2.00; 1.78 | — |
| PRIMARY Physician's Assessment of Sleep Disturbances |
2.03; 1.26 | — |
| SECONDARY Patient's Assessment of General Well-being for the Last 24 Hours (Diaries) |
5.23; 4.45; 3.62; 2.98; 2.53; 2.26 | — |
| SECONDARY Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries) |
5.75; 4.37; 3.22; 2.53; 2.05; 1.70 | — |
| SECONDARY Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries) |
4.47; 3.56; 2.72; 2.25; 1.89; 1.67 | — |
| SECONDARY Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries) |
2.64; 2.31; 1.94; 1.76; 1.62; 1.50 | — |
| SECONDARY Patient's Assessment of Nausea for the Last 24 Hours (Diaries) |
3.22; 2.52; 2.07; 1.78; 1.60; 1.42 | — |
| SECONDARY Physician's Assessment of Heartburn |
3.05; 1.33 | — |
| SECONDARY Physician's Assessment of Acid Eructation |
2.77; 1.25 | — |
| SECONDARY Physician's Assessment of Painful Swallowing |
1.76; 1.07 | — |
| SECONDARY Assessment of the Efficacy of Pantoprazole at Final Visit |
719; 246; 30; 11; 39 | — |
| SECONDARY Assessment of the Tolerability of Pantoprazole at Final Visit |
847; 150; 7; 4; 37 | — |
Summary
The aim of the study was to evaluate the effect of pantoprazole on sleep disorders in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease). The prevalence and intensity of the sleep disorders were evaluated by a standardized questionnaire. The study was expected to provide further data on safety and tolerability of pantoprazole.
Eligibility Criteria
Main inclusion criteria:
- Outpatients with erosive gastro-esophageal reflux disease (eGERD) or non-erosive reflux disease (NERD)
Main exclusion criteria:
- Criteria as defined in the respective Summary of Product Characteristics (Chapter 4.3)
Data sourced from ClinicalTrials.gov (NCT00830115). 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.