Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)
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| ClinicalTrials.gov Identifier: NCT01077076 |
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Recruitment Status :
Completed
First Posted : February 26, 2010
Results First Posted : April 2, 2010
Last Update Posted : March 11, 2015
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
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Brief Summary:
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:
- 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;
- 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.
- 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Intragastric Acidity | Drug: Zegerid Drug: Prilosec OTC™ Tablets Other: Placebo | Phase 3 |
Participants were randomized in a 3-way crossover design and received, in random order, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate), Prilosec OTC Tablets (20 mg-equivalent omeprazole), and Placebo Capsules. Participants received each treatment for 11 days. There was a minimum of a 2-week washout period between treatment arms.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Official Title: | Randomized, Placebo-Controlled, Crossover Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole |
| Study Start Date : | December 2008 |
| Actual Primary Completion Date : | March 2009 |
| Actual Study Completion Date : | March 2009 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Zegerid OTC Capsules
20 mg omeprazole and 1100 mg sodium bicarbonate
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Drug: Zegerid
Zegerid taken once daily for 11 days. |
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Active Comparator: Prilosec OTC™ tablets containing 20 mg-equivalent omeprazole
20.6 mg omeprazole-magnesium complex.
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Drug: Prilosec OTC™ Tablets
Prilosec OTC™ Tablets taken once daily for 11 days. |
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Placebo Comparator: Placebo
Inert substance
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Other: Placebo
Placebo taken once daily for 11 days. |
Primary Outcome Measures :
- Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment [ Time Frame: 4 hours after dose on Day 4 ]Early effectiveness of treatment is evaluated as the percent time with intragastric pH>4 during the first 4 hours following administration of respective treatments
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male or non-lactating, non-pregnant female subjects who are 18-65 years of age.
- Physical examination findings within normal limits for age.
Exclusion Criteria:
- History of hypersensitivity, allergy or intolerance to omeprazole, or other proton pump inhibitors
- History of peptic ulcer disease or other acid related gastrointestinal symptoms or heartburn with a frequency of more than one/month.
- Participation in any study of an investigational treatment in the 30 Days before Screening or participation in another study at any time during the period of this study
- Any significant medical illness that would contraindicate participation in the study
- Gastrointestinal disorder or surgery leading to impaired drug absorption
- Any abnormal Screening laboratory value that is clinically significant in the investigator's opinion
- Current use of any prescription or OTC medications that affect gastrointestinal function.
- Currently using or having a history of frequent use of antacids, OTC or prescription (Rx) histamine-2 (H2) receptor antagonists, or OTC or Rx use of proton pump inhibitors.
No Contacts or Locations Provided
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT01077076 History of Changes |
| Other Study ID Numbers: |
18132 P07812 ( Other Identifier: Merck ) |
| First Posted: | February 26, 2010 Key Record Dates |
| Results First Posted: | April 2, 2010 |
| Last Update Posted: | March 11, 2015 |
| Last Verified: | February 2015 |
Keywords provided by Bayer:
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Gastric Acid Human Experimentation |
Additional relevant MeSH terms:
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Omeprazole Omeprazole, sodium bicarbonate drug combination Anti-Ulcer Agents Gastrointestinal Agents |
Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |