Phase 3
Completed N=947
Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
Source: ClinicalTrials.gov NCT00321984 ↗Enrolled (actual)
947
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 — 18.5; 54.9; 50.0 percentage of days — p=<0.00001
Summary
The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily [QD] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive 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 |
18.5; 54.9; 50.0 | <0.00001 sig |
| PRIMARY Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean |
25.0; 50.3; 49.1 | — |
| SECONDARY Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median |
51.7; 80.8; 76.9 | <0.00001 sig |
| SECONDARY Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean |
47.1; 67.6; 65.0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects identifying their main symptom as a burning feeling in the mid epigastric area and/or chest area (ie, heartburn).
- Subject has a history of episodes of heartburn for 6 months or longer prior to Screening.
- Subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to Day -1.
Exclusion Criteria
- Endoscopic Barrett's esophagus and/or definite dysplastic changes. History of dilatation of esophageal strictures.
- Subjects with erosive esophagitis (EE) as shown by endoscopy.
- Evidence of uncontrolled systemic disease. Co-existing diseases affecting the esophagus. Current or history of Zollinger-Ellison syndrome.
- Subject has abnormal laboratory values.
- Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose.
- Subject known to have acquired immunodeficiency syndrome (AIDS).
- Known hypersensitivity to any proton pump inhibitor (PPI), any component of Dexlansoprazole MR, or antacid.
- Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or sucralfate.
- 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.
- Subjects who cannot discontinue the use of misoprostol or prokinetics
- Need for continuous anticoagulant therapy.
- Females who are pregnant or lactating.
- History of gastrointestinal surgery except for simple oversew of ulcer.
- History of cancer within 3 years prior to screening.
- Subject has participated in a previous Dexlansoprazole study.
- Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
Data sourced from ClinicalTrials.gov (NCT00321984). 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.