Zegerid
DrugZegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days.
Other names: omeprazole/sodium bicarbonate, SCH 900934
NCT Number: NCT01005719
This study will determine differences between Proton Pump Inhibitors (PPI) formulations relative to their effects on gastric acidity.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Zegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days.
Other names: omeprazole/sodium bicarbonate, SCH 900934
Prevacid (15 mg lansoprazole) taken with approximately 2 oz of water once daily for 7 days.
Other names: lansoprazole
Time frame: Treatment dose to 4-hr post-dose on Day 7
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.
Time frame: Treatment dose to 4-hr post-dose on Day 1
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.
Time frame: Treatment dose to 4-hr post-dose on Day 1 and Day 7
Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The difference in the onset of action was the earliest 5 minute interval (from start of interval to end of interval) for which each active treatment presented a statistically significantly advantage over No treatment based on median pH values. The earliest 5 minute interval showing the difference in onset of action is reported here.
Time frame: Treatment dose to 4-hr post-dose on Day 1 and Day 7
The time required to achieve an intragastric pH ≥3.5 that is reached for 10 consecutive minutes after drug administration on the 1st and 7th days of dosing.
Time frame: Treatment dose to 4 hours Post-dose on Day 7
Time frame: Treatment dose to 24-hour post-dose on Day 7
The median intragastric pH values were recorded over a 24-hr period.
Time frame: Treatment dose to 24-hour post-dose on Day 7
Time frame: Treatment dose to 24-hours post-dose on Day 7
Time frame: Treatment dose to 24-hour post-dose on Day 7
Number of participants maintaining intragastric pH > 4 for at least 12 hrs at
steady-state on Day 7
Time frame: Treatment dose to 24-hour post-dose on Day 7
Number of participants maintaining intragastric pH > 3.5 for at least 12 hrs at
steady-state on Day 7
Time frame: Treatment dose to 24-hour post-dose on Day 7
Time frame: Treatment dose to 2-hours post-dose on Day 7
The first time to sustain median pH > 3.5 for at least 3 successive 5-minute periods within the first 2 hours after dosing with Zegerid Capsules, and Prevacid Capsules, or No treatment on the 7th day of respective treatments. If this condition was not met for any time point within the first 2 hours following dosing, a score of 120 minutes was imputed.
Time frame: Treatment dose to onset of event on Day 1
The onset of inhibition of acid secretion was the first time to sustain median pH >3.5 for each of the twenty-four successive 5-minute periods. If this condition was not met for any time point within the first 4 hours following dosing, a score of 240 minutes was imputed.
Time frame: Treatment dose to 24-hr post-dose on Day 1
Time frame: Treatment dose to 24-hr post-dose on Day 1
Time frame: Treatment dose to 24-hour post-dose on Day 1
Time frame: Treatment dose to 4-hours post-dose on Day 1
Time frame: Treatment dose to event on Day 1 and Day 7
The earliest time during the first 4 hours after dosing that the median
pH for the treatment is over 1 unit higher than that for the No treatment during the next three 5 minute intervals. (When this condition does not occur, the time to sustained advantage will be imputed as 4 hours.)
Bayer
Industry
Randomized, Crossover, Pharmacodynamic Study Comparing the Effects of Two Proton Pump Inhibitors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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