CLINICAL TRIALS PROFILE FOR ZEGERID
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505(b)(2) Clinical Trials for Zegerid
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT01077076 ↗ | Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED) | Completed | Bayer | Phase 3 | 2008-12-01 | This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to: 1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments; 2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing. 3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Zegerid
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00557349 ↗ | Ulcer Prevention Study in Post Gastric Bypass Patients | Completed | University of Missouri-Columbia | Phase 4 | 2006-11-01 | This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer after gastric bypass surgery. |
| NCT00674115 ↗ | A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED) | Completed | Bausch Health Americas, Inc. | Phase 3 | 2008-04-01 | Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate. |
| NCT00674115 ↗ | A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED) | Completed | Valeant Pharmaceuticals International, Inc. | Phase 3 | 2008-04-01 | Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate. |
| NCT00674115 ↗ | A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED) | Completed | Bayer | Phase 3 | 2008-04-01 | Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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