Phase 3
Completed N=366
Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs
Stomach Ulcer · Duodenal Ulcer
Source: ClinicalTrials.gov NCT00787254 ↗
Enrolled (actual)
366
Serious AEs
12.6%
Results posted
May 2011
Primary outcomePrimary: Number of Participants With Gastric Ulcer and/or Duodenal Ulcer — 15; 46 participants — p=<0.0001
Summary
The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice daily (BID).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Gastric Ulcer and/or Duodenal Ulcer |
15; 46 | <0.0001 sig |
| SECONDARY Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) |
-0.114; 0.429 | 0.0002 sig |
| SECONDARY Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) |
-0.319; 0.188 | 0.0041 sig |
| SECONDARY Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) |
-0.231; 0.048 | 0.0652 |
| SECONDARY Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18) |
-0.162; -0.278 | 0.9836 |
| SECONDARY Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24) |
-0.800; NA | — |
| SECONDARY Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) |
-0.102; 0.142 | 0.0001 sig |
| SECONDARY Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) |
-0.095; 0.047 | 0.0161 sig |
| SECONDARY Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) |
-0.177; 0.048 | 0.0068 sig |
| SECONDARY Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18) |
-0.297; -0.056 | 0.2363 |
| SECONDARY Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24) |
-0.200; NA | — |
| SECONDARY Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage) |
15; 52 | <0.0001 sig |
| SECONDARY Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3) |
-0.006; 0.014 | 0.4788 |
| SECONDARY Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6) |
0.027; 0.000 | 0.6607 |
| SECONDARY Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12) |
-0.014; -0.020 | 0.8811 |
| SECONDARY Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18) |
0.000; 0.000 | 1.0000 |
| SECONDARY Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24) |
NA | — |
| SECONDARY Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3) |
-0.044; 0.014 | 0.2060 |
| SECONDARY Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6) |
0.009; -0.036 | 0.5099 |
| SECONDARY Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12) |
-0.029; -0.061 | 0.7794 |
| SECONDARY Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18) |
0.000; 0.000 | 1.0000 |
| SECONDARY Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24) |
NA | — |
| SECONDARY Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3) |
-0.025; -0.014 | 0.6980 |
| SECONDARY Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6) |
0.000; -0.048 | 0.4599 |
| SECONDARY Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12) |
-0.057; -0.204 | 0.0355 sig |
| SECONDARY Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18) |
-0.056; 0.000 | 0.7325 |
| SECONDARY Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24) |
NA | — |
| SECONDARY Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3) |
-0.006; 0.007 | 0.8262 |
| SECONDARY Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6) |
0.009; -0.012 | 0.7244 |
| SECONDARY Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12) |
-0.043; -0.041 | 0.9566 |
| SECONDARY Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18) |
0.000; -0.091 | 0.2008 |
| SECONDARY Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24) |
NA | — |
| SECONDARY Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3) |
-0.057; 0.058 | 0.0703 |
| SECONDARY Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6) |
-0.027; -0.095 | 0.3046 |
| SECONDARY Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12) |
-0.114; -0.102 | 0.7121 |
| SECONDARY Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18) |
-0.056; 0.091 | 0.1522 |
| SECONDARY Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24) |
-1.000 | — |
| SECONDARY Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3) |
0.006; 0.022 | 0.5328 |
| SECONDARY Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6) |
0.036; 0.024 | 0.7223 |
| SECONDARY Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12) |
0.014; -0.020 | 0.3117 |
| SECONDARY Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18) |
0.056; 0.000 | 0.4344 |
| SECONDARY Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24) |
NA | — |
| SECONDARY Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3) |
0.006; -0.007 | 0.1571 |
| SECONDARY Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6) |
0.000; 0.012 | 0.2503 |
| SECONDARY Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12) |
0.043; 0.000 | 0.4028 |
| SECONDARY Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18) |
0.000; 0.000 | 1.0000 |
| SECONDARY Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24) |
NA | — |
| SECONDARY Number of Participants With Adverse Events |
154; 125; 83; 64; 28; 28 | — |
Eligibility Criteria
Inclusion Criteria
- The patient was on nonsteroid anti-inflammatory drug (NSAID) treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.
- The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.
Exclusion Criteria
- Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.
- Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.
- Current or past history of aspirin-induced asthma or hypersensitivity to NSAIDs.
- Past or planned surgery affecting gastric acid secretion.
- Clinically significant hepatic or renal disorder.
- Serious cardiac dysfunction, hypertension, or hematological disorder.
Data sourced from ClinicalTrials.gov (NCT00787254). 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.