Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zegerid · 2 trials · 2 indications
Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here.
Early effectiveness of treatment is evaluated as the percent time with intragastric pH\>4 during the first 4 hours following administration of respective treatments
| Arm | Type | Description |
|---|---|---|
| Zegerid | EXPERIMENTAL | Participants receiving Zegerid (omeprazole/sodium bicarbonate) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants also took approximately 2 oz of water with their medication. |
| Prevacid® | ACTIVE_COMPARATOR | Participants receiving Prevacid® (lansoprazole) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants also took approximately 2 oz of water with their medication. |
| No treatment | NO_INTERVENTION | Participants receiving No treatment in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants took approximately 2 oz of water once daily for 7 days. |
| Zegerid OTC Capsules | EXPERIMENTAL | 20 mg omeprazole and 1100 mg sodium bicarbonate |
| Prilosec OTC™ tablets containing 20 mg-equivalent omeprazole | ACTIVE_COMPARATOR | 20.6 mg omeprazole-magnesium complex. |
| Placebo | PLACEBO_COMPARATOR | Inert substance |
| Name | Type | Description |
|---|---|---|
| Zegerid | DRUG | Zegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days. |
| Prevacid® | DRUG | Prevacid (15 mg lansoprazole) taken with approximately 2 oz of water once daily for 7 days. |
| Prilosec OTC™ Tablets | DRUG | Prilosec OTC™ Tablets taken once daily for 11 days. |
| Placebo | OTHER | Placebo taken once daily for 11 days. |
Inclusion Criteria: * Healthy non-Asian, male or non-lactating, non-pregnant female participants who are 18-65 years of age. * Clinical laboratory test must be within normal limits or clinically acceptable to the Investigator/Sponsor. * Participants must have normal or clinically acceptable physica...
Zegerid is a small molecule being studied for the management of intragastric acidity. It is an investigational drug in Phase 3 clinical development, evaluated in healthy volunteers to assess its effects on gastric acid suppression. It has not been approved by regulatory authorities and remains under clinical investigation.
Zegerid is being developed by Bayer AG, a pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The drug is currently in Phase 3 clinical trials for the treatment of intragastric acidity.
Zegerid is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy for managing intragastric acidity.
Zegerid has been studied in two completed Phase 3 clinical trials. One trial, NCT01005719, compared gastric inhibition of two proton pump inhibitors with 63 participants. Another trial, NCT01077076, compared the effects of two different forms of omeprazole with 30 participants. Both trials involved healthy volunteers.
Zegerid is a form of omeprazole, a proton pump inhibitor. Clinical trials have compared Zegerid to other omeprazole formulations to evaluate their effects on intragastric acidity. Zegerid is being developed by Bayer AG and is currently in Phase 3 clinical development.