Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01757275 | High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer | PHASE3 | COMPLETED | 239 | — | — | Feb 1, 2013 | Dec 1, 2014 | Mar 8, 2016 | 12 | China |
Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb \>20g/L (or Hct \>6%) during 24 hours or an increase in Hb \<10g/L (or Hct \<3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (\>200 ml) of fresh blood as estimated by the investigator.
| Arm | Type | Description |
|---|---|---|
| Esomeprazole | EXPERIMENTAL | - |
| Cimetidine | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Esomeprazole Na | DRUG | Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous |
| Cimetidine | DRUG | Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours |
| Esomeprazole Mg | DRUG | 40 mg tablet once daily for 27 days |
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures. * Female or male aged =18 years and =70 years. * Acute upper gastrointestinal bleeding (haematemesis, melaena or haematochezia) or such signs within the last 24 hours as judged by the investigator. * One end...