Phase 3
Completed N=908
Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Source: ClinicalTrials.gov NCT00251745 ↗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·
- 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.
- Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the screening endoscopy.
- 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
- 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 (NCT00251745). 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.