Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ranitidine · 4 trials · 3 indications
Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment. (Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent).
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 20mg Oral tablet daily |
| 2 | EXPERIMENTAL | 40mg Oral tablet daily |
| 3 | ACTIVE_COMPARATOR | 150mg oral twice daily |
| Part A1 | ACTIVE_COMPARATOR | 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference), fed 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed |
| Part A2 | ACTIVE_COMPARATOR | 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed 150 mg ranitidine |
| Part B1 | ACTIVE_COMPARATOR | 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A) |
| Part B2 | ACTIVE_COMPARATOR | 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B) |
| Part B3 | ACTIVE_COMPARATOR | 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) |
| Name | Type | Description |
|---|---|---|
| Esomeprazole | DRUG | - |
| Ranitidine | DRUG | - |
| Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) | DRUG | 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) |
| Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed | DRUG | 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed |
| Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A) | DRUG | 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A) |
| Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B) | DRUG | 1 x 150mg mannitol based 38% drug loaded tablet(batch variant B) |
Inclusion Criteria: * Signed informed consent. * A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 2 months. * Daily NSAID dose and type must have been stable for at least 2 weeks prior to the baseline endoscopy;orally; Exclusion Criteria: * History of e...
Ranitidine is a small molecule gastrointestinal drug studied for the treatment of gastric ulcers and NSAID-associated gastric ulcers. It has been evaluated in Phase 3 clinical trials as an active comparator against esomeprazole for healing these conditions. It has also been used in a pharmacokinetic study to assess drug interactions.
Ranitidine is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca has sponsored Phase 3 clinical trials comparing ranitidine with its own product esomeprazole for the healing of gastric ulcers and NSAID-associated gastric ulcers.
Ranitidine has been studied in Phase 3 clinical trials for gastric ulcer and NSAID-associated gastric ulcer indications. These trials are completed. It is also used in a Phase 1 pharmacokinetic study. Ranitidine is an investigational drug in these contexts and is not stated to be FDA approved.
Ranitidine has been studied in completed Phase 3 trials: NCT00401752 compared esomeprazole 20mg qd vs ranitidine 150mg bid in patients with NSAID-induced gastric ulcer, and NCT00633412 and NCT00633672 compared Nexium (esomeprazole) 40mg qd and 20mg qd vs ranitidine 150mg bid for healing NSAID-associated gastric ulcers. A Phase 1 trial, NCT01682408, assessed pharmacokinetics of fostamatinib with ranitidine.
Ranitidine is a histamine H2-receptor antagonist that reduces stomach acid production. It works by blocking histamine from binding to H2 receptors on gastric parietal cells, thereby decreasing acid secretion. This mechanism helps heal gastric ulcers and NSAID-associated gastric ulcers.