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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05267613 | Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis. | PHASE3 | ACTIVE NOT_RECRUITING | 53 | — | — | Jul 1, 2022 | Aug 19, 2026 | Apr 22, 2026 | 42 | United States, Argentina +8 |
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...