Phase 3
Completed N=908
Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Source: ClinicalTrials.gov NCT00251758 ↗Enrolled (actual)
908
Serious AEs
—
Results posted
Mar 2009
Primary outcomePrimary: Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median — 17.0; 45.7; 52.7 percentage of days — p=<0.00001
Summary
The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily [QD]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median |
17.0; 45.7; 52.7 | <0.00001 sig |
| PRIMARY Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean |
24.9; 44.8; 49.1 | — |
| SECONDARY Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median |
51.0; 72.3; 76.6 | 0.00001 sig |
| SECONDARY Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean |
49.6; 62.0; 64.4 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn.
- History of episodes of heartburn for 6 months or longer prior to screening.
- History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary.
Exclusion Criteria
- Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study
- Erosive Esophagitis seen on endoscopy during study screening.
- Co-existing diseases affecting the esophagus.
- Abnormal laboratory values that suggest significant clinical disease.
- Known acquired immunodeficiency syndrome (AIDS)
- Females pregnant or lactating.
- History of Alcohol abuse.
- History of Cancer within 3 years prior to screening.
- Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors
- Use of antacids (except for study supplied Gelusil® )
- Use of drugs with significant anticholinergic effects
- Need for continuous anticoagulant (blood thinner) therapy
- Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
- History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
- Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition
- History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer
- Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
- Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy
Data sourced from ClinicalTrials.gov (NCT00251758). 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.