N/A
N=8,616
Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS)
Erosive Gastroesophageal Reflux Disease · Non-Erosive Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT00562094 ↗Enrolled (actual)
8,616
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcome: Primary: Assessment of the Severity of Sleep Disturbances — 13.8; 77.4; 38.2; 20.0 percentage of participants
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
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of the Severity of Sleep Disturbances |
13.8; 77.4; 38.2; 20.0; 35.9; 1.1 | — |
| PRIMARY Assessment of Change of Quality of Sleep During Therapy With Pantoprazole |
56.2; 25.7; 13.5; 4.6 | — |
| SECONDARY Assessment of the Severity of Heartburn |
3.04; 1.34 | — |
| SECONDARY Assessment of the Severity of Eructation/Acid Eructation |
2.66; 1.29 | — |
| SECONDARY Assessment of the Severity of Epigastric Complaints/Epigastric Pain |
2.25; 1.18 | — |
| SECONDARY Assessment of the Severity of Sensation of Fullness/Abdominal Distension |
2.35; 1.28 | — |
| SECONDARY Assessment of the Efficacy of Pantoprazole at Final Visit |
78.1; 19.6; 1.3; 0.2; 0.8 | — |
| SECONDARY Assessment of the Tolerability of Pantoprazole at Final Visit |
81.6; 14.8; 0.4; 0.06; 3.1 | — |
Summary
The aim of the study was to evaluate the effect of Pantoprazole 20 mg/40 mg for 14 days on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) with special focus on the reduction of symptomatic sleep disorders.
Eligibility Criteria
Main inclusion criteria:
- GERD
- NERD
Main exclusion criteria:
- Criteria as defined in the Summary of Product Characteristics
Data sourced from ClinicalTrials.gov (NCT00562094). 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.