Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01077076
First received: February 25, 2010
Last updated: January 14, 2015
Last verified: January 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Intragastric Acidity |
Drug: Zegerid Drug: Prilosec OTC™ Tablets Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Randomized, Placebo-Controlled, Crossover Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
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 ] [ Designated as safety issue: No ]Early effectiveness of treatment is evaluated as the percent time with intragastric pH>4 during the first 4 hours following administration of respective treatments
| Enrollment: | 30 |
| Study Start Date: | December 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Zegerid OTC Capsules
20 mg omeprazole and 1100 mg sodium bicarbonate
|
Drug: Zegerid
Zegerid taken once daily for 11 days.
|
|
Active Comparator: Prilosec OTC™ tablets containing 20 mg-equivalent omeprazole
20.6 mg omeprazole-magnesium complex.
|
Drug: Prilosec OTC™ Tablets
Prilosec OTC™ Tablets taken once daily for 11 days.
|
|
Placebo Comparator: Placebo
Inert substance
|
Other: Placebo
Placebo taken once daily for 11 days.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
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More Information
No publications provided
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT01077076 History of Changes |
| Other Study ID Numbers: | P07812 |
| Study First Received: | February 25, 2010 |
| Results First Received: | March 11, 2010 |
| Last Updated: | January 14, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck Sharp & Dohme Corp.:
|
Gastric Acid Human Experimentation |
Additional relevant MeSH terms:
|
Omeprazole Anti-Ulcer Agents Enzyme Inhibitors Gastrointestinal Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Proton Pump Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 26, 2015