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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00674115 | A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED) | PHASE3 | COMPLETED | 60 | — | — | Apr 1, 2008 | Jun 1, 2008 | Mar 11, 2015 | - | — |
The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. PH measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.
| Arm | Type | Description |
|---|---|---|
| Single Dose Zegerid for 1 or 7 days | EXPERIMENTAL | Omeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension |
| Single Dose Prilosec 1 or 7 days | ACTIVE_COMPARATOR | Omeprazole magnesium 20 mg over-the-counter (OTC) Tablet |
| Sodium Bicarbonate | ACTIVE_COMPARATOR | Sodium Bicarbonate 1680 mg Oral Suspension |
| Name | Type | Description |
|---|---|---|
| Omeprazole/sodium bicarbonate | DRUG | Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days. |
| omeprazole magnesium | DRUG | Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days. |
| sodium bicarbonate | DRUG | Sodium bicarbonate. Single dose. |
Inclusion Criteria: * Normal subjects who are 18-65 years of age. * Non-childbearing potential females or those using birth control. Exclusion Criteria: * History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors * History of significant gastrointestinal di...