Phase 3
Completed N=591
Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Source: ClinicalTrials.gov NCT00255190 ↗Enrolled (actual)
591
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Mean Change From Baseline to Month 12 for Hemoglobin Values — -0.29; -0.05 g/dL — p=0.042
Summary
The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to Month 12 for Hemoglobin Values |
-0.29; -0.05 | 0.042 sig |
| PRIMARY Mean Change From Baseline to Month 12 for Hematocrit Values |
-1.98; -0.93 | 0.006 sig |
| PRIMARY Mean Change From Baseline to Month 12 for Red Blood Cell Count Values |
-0.31; -0.11 | <0.001 sig |
| PRIMARY Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values |
0.67; 0.56 | 0.494 |
| PRIMARY Mean Change From Baseline to Month 12 for Platelet Count Values |
-12.7; -1.9 | 0.026 sig |
| PRIMARY Mean Change From Baseline to Month 12 for White Blood Cell Count Values |
-0.20; 0.04 | 0.220 |
| PRIMARY Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values |
0.1; 0.0 | 0.843 |
| PRIMARY Mean Change From Baseline to Month 12 for Creatinine Values |
-0.04; -0.04 | 0.923 |
| PRIMARY Mean Change From Baseline to Month 12 for Calcium Values |
-0.25; -0.04 | <0.001 sig |
| PRIMARY Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values |
0.09; 0.06 | 0.758 |
| PRIMARY Mean Change From Baseline to Month 12 for Total Bilirubin Values |
-0.02; -0.01 | 0.737 |
| PRIMARY Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values |
0.4; -0.4 | 0.673 |
| PRIMARY Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values |
0.9; 0.6 | 0.817 |
| PRIMARY Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values |
1.6; 0.5 | 0.601 |
| PRIMARY Mean Change From Baseline to Month 12 for Serum Gastrin Levels |
155.8; 115.4 | 0.065 |
| PRIMARY Mean Change From Baseline to Month 12 for Systolic Blood Pressure |
3.8; 1.9 | 0.319 |
| PRIMARY Mean Change From Baseline to Month 12 for Diastolic Blood Pressure |
4.0; 0.6 | 0.011 sig |
| PRIMARY Mean Change From Baseline to Month 12 for Pulse Rate |
0.5; -1.3 | 0.207 |
| PRIMARY Changes From Baseline to Final Visit in Antrum Biopsy Results |
39; 114; 11; 61; 21; 47 | — |
| PRIMARY Changes From Baseline to Final Visit in Fundus Biopsy Results |
55; 198; 8; 35; 17; 33 | — |
| SECONDARY Mean Change From Baseline to Month 1 for PAGI-QOL Total Score |
0.54; 0.54 | 0.204 |
| SECONDARY Mean Change From Baseline to Month 3 for PAGI-QOL Total Score |
0.61; 0.56 | 0.109 |
| SECONDARY Mean Change From Baseline to Month 6 for PAGI-QOL Total Score |
0.58; 0.56 | 0.286 |
| SECONDARY Mean Change From Baseline to Month 9 for PAGI-QOL Total Score |
0.64; 0.60 | 0.102 |
| SECONDARY Mean Change From Baseline to Month 12 for PAGI-QOL Total Score |
0.56; 0.61 | 0.656 |
| SECONDARY Mean Change From Baseline to Month 1 for PAGI-SYM Total Score |
-0.95; -0.85 | 0.176 |
| SECONDARY Mean Change From Baseline to Month 3 for PAGI-SYM Total Score |
-1.09; -0.91 | 0.030 sig |
| SECONDARY Mean Change From Baseline to Month 6 for PAGI-SYM Total Score |
-1.05; -0.93 | 0.243 |
| SECONDARY Mean Change From Baseline to Month 9 for PAGI-SYM Total Score |
-1.17; -0.89 | 0.005 sig |
| SECONDARY Mean Change From Baseline to Month 12 for PAGI-SYM Total Score |
-1.08; -0.95 | 0.469 |
Eligibility Criteria
Inclusion Criteria
- Subjects must have successfully completed either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis.
Exclusion Criteria
- Any condition that may require inpatient surgery during the course of the study.
- Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study.
- Use of antacids [except for study supplied Gelusil®].
- Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study.
- Evidence of uncontrolled systemic disease.
- Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid.
- Need to take blood thinners.
- Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month.
- Had cancer (except basal cell cancer of the skin) within 3 years prior to screening.
- Has other esophageal disease including Barrett's esophagus or strictures requiring dilation.
- Has had radiation or cryotherapy to the esophagus.
- Has active gastric or duodenal ulcers within 4 weeks of starting study drug.
- Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome.
- History of alcohol abuse.
- Has acquired immunodeficiency syndrome.
- Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy.
- Received a blood product transfusion within 3 months of taking the first dose of study drug.
- Has previously participated in another dexlansoprazole MR long-term treatment clinical trial.
Data sourced from ClinicalTrials.gov (NCT00255190). 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.