Gastric AcidPhase 3NCT00674115
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)
A Phase 3 study testing Omeprazole/sodium bicarbonate, omeprazole magnesium and sodium bicarbonate in people with Gastric Acid and Human Experimentation, run by Bayer.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Acid, Human Experimentation
- What is being tested?
- Omeprazole/sodium bicarbonate, omeprazole magnesium and sodium bicarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal subjects who are 18-65 years of age.
- Non-childbearing potential females or those using birth control.
Who cannot join
- History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors
- History of significant gastrointestinal disease
- Any significant medical illness
- Gastrointestinal disorder or surgery leading to impaired drug absorption
- Currently using gastrointestinal medications
About this study
Official title: Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® (20 Mg-equivalent Omeprazole)
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.
Read the detailed description
Enrolled participants were divided into 2 groups, with 30 participants in each group.
Group 1: This group was randomized into a 2-way crossover design with an added third period. These participants received single administrations (day 1 dosing only) of Zegerid Powder for Oral Suspension, and Prilosec OTC (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. Following completion of the 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate (at same dose as contained in Zegerid Powder for Oral Suspension) in Period 3. This group underwent a 24-hour intragastric pH study on each of the 3 dosing occasions.
Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid Powder for Oral Suspension and Prilosec OTC tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group also underwent 24-hour intragastric pH recordings on the days on which they received their 1st and last (7th) dose of the two treatment drugs.
In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC and Zegerid Powder for Oral Suspension on change in intragastric pH during the subsequent 24-hour period following the first dose.
- Conditions
- Gastric Acid, Human Experimentation
- Being tested
- Omeprazole/sodium bicarbonate, omeprazole magnesium, sodium bicarbonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole/sodium bicarbonateDrug
Also called Zegerid
Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.
omeprazole magnesiumDrug
Also called Prilosec OTC Tablet
Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.
sodium bicarbonateDrug
Sodium bicarbonate. Single dose.
| Study group | Role | What they receive |
|---|---|---|
| Single Dose Zegerid for 1 or 7 days | Experimental | Omeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension Receives: Drug: Omeprazole/sodium bicarbonate |
| Single Dose Prilosec 1 or 7 days | Active comparator | Omeprazole magnesium 20 mg over-the-counter (OTC) Tablet Receives: Drug: omeprazole magnesium |
| Sodium Bicarbonate | Active comparator | Sodium Bicarbonate 1680 mg Oral Suspension Receives: Drug: sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration
The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. PH measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.
Measured: Baseline and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric AcidStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674115
- Sponsor's protocol ID
- 18133
- Other IDs
- CL2007-17, P07813
- Status last verified
- Feb 2015
- First submitted
- 2 May 2008
- Last updated
- 11 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® (20 Mg-equivalent Omeprazole)
- ClinicalTrials.gov ID
- NCT00674115
- Acronym / sponsor ID
- 18133
- Conditions
- Gastric Acid, Human Experimentation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Posted 30 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Enrolled participants were divided into 2 groups, with 30 participants in each group.
Group 1: This group was randomized into a 2-way crossover design with an added third period. These participants received single administrations (day 1 dosing only) of Zegerid Powder for Oral Suspension, and Prilosec OTC (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. Following completion of the 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate (at same dose as contained in Zegerid Powder for Oral Suspension) in Period 3. This group underwent a 24-hour intragastric pH study on each of the 3 dosing occasions.
Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid Powder for Oral Suspension and Prilosec OTC tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group also underwent 24-hour intragastric pH recordings on the days on which they received their 1st and last (7th) dose of the two treatment drugs.
In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC and Zegerid Powder for Oral Suspension on change in intragastric pH during the subsequent 24-hour period following the first dose.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Dose Zegerid for 1 or 7 days | Experimental | Drug: Omeprazole/sodium bicarbonateOmeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension |
| Single Dose Prilosec 1 or 7 days | Active comparator | Drug: omeprazole magnesiumOmeprazole magnesium 20 mg over-the-counter (OTC) Tablet |
| Sodium Bicarbonate | Active comparator | Drug: sodium bicarbonateSodium Bicarbonate 1680 mg Oral Suspension |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Normal subjects who are 18-65 years of age.
- Non-childbearing potential females or those using birth control.
Key exclusion criteria (5 listed)
- History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors
- History of significant gastrointestinal disease
- Any significant medical illness
- Gastrointestinal disorder or surgery leading to impaired drug absorption
- Currently using gastrointestinal medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omeprazole/sodium bicarbonateAlso: ZegeridOmeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days. | Drug | Single Dose Zegerid for 1 or 7 days |
| omeprazole magnesiumAlso: Prilosec OTC TabletOmeprazole 20 mg tablet. Single dose per day for either 1 or 7 days. | Drug | Single Dose Prilosec 1 or 7 days |
| sodium bicarbonateSodium bicarbonate. Single dose. | Drug | Sodium Bicarbonate |
Primary outcome
Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration
Time frame: Baseline and 7 days
The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. PH measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omeprazole/sodium bicarbonate, omeprazole magnesium and sodium bicarbonate in people with Gastric Acid and Human Experimentation, run by Bayer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration (time frame: Baseline and 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.