Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cimetidine · 2 trials · 2 indications
Criteria for a clinically significant upper GI bleeding as: 1. Bright red blood per NG or OG tube that did not clear after NG or OG tube adjustment and 5 to 10 minutes of at least 100 ml lavage with room temperature normal saline-or, 2. Persistent gastroccult- positive coffee ground material During IMP treatment Day 1-2: Persistent gastroccult- positive coffee ground material for at least eight consecutive hours that did not clear with at least 100 ml of lavage with room temperature normal saline. During IMP treatment Day 3-14: Persistent gastroccult- positive coffee ground material in at least three consecutive gastric aspirates within 2 to 4 hours (at least 60 ±20 minutes apart), that did not clear with at least 100 ml of lavage with room temperature normal saline.
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 active treatment | EXPERIMENTAL | iv esomeprazole 30 min intermittent infusions given for maximum 14 days |
| Cimetidine active treatment | ACTIVE_COMPARATOR | iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days |
| Esomeprazole | EXPERIMENTAL | - |
| Cimetidine | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Esomeprazole | DRUG | iv esomeprazole 30 min intermittent infusions given for maximum 14 days |
| Cimetidine | DRUG | iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days |
| Esomeprazole Na | DRUG | Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous |
| Esomeprazole Mg | DRUG | 40 mg tablet once daily for 27 days |
Inclusion Criteria: 1. Critically ill patients 2. Requirement for mechanical ventilation 3. At least one major risk factor for stress ulcer related bleeding Exclusion Criteria: 1. History of gastric or oesophageal surgery 2. Evidence of active GI bleeding 3. Advanced renal disease 4. Treatment wi...
Cimetidine is a small molecule used for stress ulcer prophylaxis and bleeding peptic ulcer. It is being developed by AstraZeneca PLC (AZN) and is currently in Phase 3 clinical development. The drug is administered to patients in a hospital setting to prevent or treat gastrointestinal bleeding.
Cimetidine is being developed by AstraZeneca PLC, a pharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the drug's efficacy and safety for the prevention and treatment of gastrointestinal ulcers.
Cimetidine is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trials are designed to confirm its effectiveness and monitor side effects in a larger patient population.
Cimetidine has been studied in two completed Phase 3 trials. One trial (NCT01757275) evaluated high-dose esomeprazole for preventing rebleeding after endoscopic therapy in patients with bleeding peptic ulcer, enrolling 239 participants. Another trial (NCT02157376) assessed stress ulcer prophylaxis in 343 seriously ill patients in China.
Cimetidine is not the same as esomeprazole. While both are used for gastrointestinal conditions, the clinical trials listed for Cimetidine actually compare it to esomeprazole. Cimetidine is a histamine H2-receptor antagonist, whereas esomeprazole is a proton pump inhibitor, and they work through different mechanisms.