N/A
Completed N=4,188
Efficacy of Pantoprazole 20/40 mg Once Daily (od) in Patients Older Than 12 Years Who Have Gastrointestinal Symptoms of Reflux Disease
Source: ClinicalTrials.gov NCT00829738 ↗Enrolled (actual)
4,188
Serious AEs
0.1%
Results posted
Sep 2010
Primary outcomePrimary: Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn — 3.10; 1.36 units on a scale
Summary
The aim of this study was to evaluate the effect of 14 days treatment with Pantoprazole 40 mg and 20 mg on gastroesophageal reflux disease (GERD) related symptoms in a large patient population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn |
3.10; 1.36 | — |
| PRIMARY Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation |
2.75; 1.30 | — |
| PRIMARY Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing |
1.87; 1.06 | — |
| PRIMARY Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms |
79.0; 19.2; 1.2; 0.1; 0.5 | — |
| SECONDARY Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain |
2.21; 1.17 | — |
| SECONDARY Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness |
2.35; 1.26 | — |
| SECONDARY Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea |
1.75; 1.07 | — |
| SECONDARY Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms |
67.3; 26.0; 2.2; 0.4; 4.2 | — |
| SECONDARY Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain |
1.39; 1.06 | — |
| SECONDARY Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea |
1.26; 1.05 | — |
| SECONDARY Irritable Bowel Syndrome: Assessment of the Severity of Constipation |
1.19; 1.06 | — |
| SECONDARY Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome |
53.9; 25.1; 5.9; 0.7; 14.4 | — |
| SECONDARY Assessment of the Tolerability of Pantoprazole at Final Visit |
84.5; 14.3; 0.5; 0.02; 0.7 | — |
Eligibility Criteria
Main inclusion criteria:
- Outpatients with gastroesophageal reflux disease (GERD)
Main exclusion criteria:
- Criteria as defined in the Summary of Product Characteristics
Data sourced from ClinicalTrials.gov (NCT00829738). 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.