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Also known as Nexium 20mg
Nexium · 1 trial · 1 indication
Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 16-week maintenance phase
| Arm | Type | Description |
|---|---|---|
| Nexium - high dose | ACTIVE_COMPARATOR | Arm 1 (High dose = Healing dose) |
| Nexium - Low dose | ACTIVE_COMPARATOR | Arm 2 (Low dose = ½ healing dose) |
| Name | Type | Description |
|---|---|---|
| Nexium 20mg | DRUG | Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks. |
| Nexium 10mg | DRUG | Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks. |
Inclusion Criteria: 1. Patient must be 1 to 11 years of age 2. Patients must have a clinical history of GERD for at least 3 months before the start of study 3. For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase...
Nexium is used for the treatment of Erosive Esophagitis, a condition where stomach acid damages the esophagus. It is being studied in pediatric patients aged 1 to 11 years to evaluate endoscopic evidence of maintenance of healing. The drug is administered orally and is currently in Phase 3 clinical development.
Nexium targets the gastric proton pump, specifically the H+/K+-ATPase enzyme in stomach parietal cells. By inhibiting this enzyme, Nexium reduces gastric acid secretion, which helps heal and maintain healing of erosive esophagitis. This mechanism is well-established for proton pump inhibitors in gastrointestinal disorders.
Nexium is developed by AstraZeneca PLC, a global biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate Nexium's efficacy and safety in pediatric patients with erosive esophagitis, with the drug currently in Phase 3 development.
Nexium is in Phase 3 clinical development for the treatment of Erosive Esophagitis. It is an investigational drug in this pediatric indication and has not yet received regulatory approval for this use. The ongoing Phase 3 trial is active but not recruiting participants, indicating advanced stages of clinical evaluation.
Nexium is being evaluated in a Phase 3 clinical trial with the identifier NCT05267613. This randomized, double-blind, active-controlled study assesses endoscopic evidence of maintenance of healing with oral Nexium in patients aged 1 to 11 years with erosive esophagitis. The trial enrolls 53 participants across multiple countries including the United States, Argentina, Australia, and several European nations.
Yes, Nexium 20mg is a specific dosage form of Nexium. The drug is also known as Nexium 20mg, which refers to the 20 milligram strength of the medication. Both names refer to the same active ingredient, esomeprazole, which is being studied in the Phase 3 trial for erosive esophagitis in pediatric patients.