Normal Healthy Subject PopulationPhase 4NCT00808769
Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression
A Phase 4 study testing Zegerid® and Prilosec OTC® in people with Normal Healthy Subject Population, run by Procter and Gamble at 1 site in United States.
Trial summary
The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Subject Population
- What is being tested?
- Zegerid® and Prilosec OTC®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Dec 2008
- Phase
- Phase 4
- 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 significant GI disease
- Any significant medical illness
- History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors;
- Currently using GI medications
- GI disorder or surgery leading to impaired drug absorption
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.
- Conditions
- Normal Healthy Subject Population
- Being tested
- Zegerid®, Prilosec OTC®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zegerid®Drug
capsule(20 mg omeprazole/sodium bicarbonate), single dose
Prilosec OTC®Drug
Omeprazole-magnesium 20.6 mg, tablet, single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Zegerid® Receives: Drug: Zegerid® |
| 2 | Experimental | Prilosec OTC® Receives: Drug: Prilosec OTC® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mean Percent Time Gastric pH > 4.0 on Day 1
In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH < 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.
Measured: continuously over a 24 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionDec 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 Normal Healthy Subject PopulationStudies of the same condition, open and under way.
- 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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John McRorie, PhD, FACG, AGAF, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808769
- Sponsor's protocol ID
- 2008122
- Status last verified
- May 2015
- First submitted
- 15 Dec 2008
- Last updated
- 1 Jun 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 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression
- ClinicalTrials.gov ID
- NCT00808769
- Acronym / sponsor ID
- 2008122
- Conditions
- Normal Healthy Subject Population
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Dec 2008 (estimated)
- Results
- Posted 27 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Zegerid®Zegerid® |
| 2 | Experimental | Drug: Prilosec OTC®Prilosec OTC® |
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 significant GI disease
- Any significant medical illness
- History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors;
- Currently using GI medications
- GI disorder or surgery leading to impaired drug absorption
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 |
|---|---|---|
| Zegerid®capsule(20 mg omeprazole/sodium bicarbonate), single dose | Drug | 1 |
| Prilosec OTC®Omeprazole-magnesium 20.6 mg, tablet, single dose | Drug | 2 |
Primary outcome
The Mean Percent Time Gastric pH > 4.0 on Day 1
Time frame: continuously over a 24 hour period
In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH < 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Normal Healthy Subject Population
RecruitingPhase 1
FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients
Healthy Participants, Atopic Dermatitis
RecruitingPhase 1
A Study of HL40626S Tablets in Healthy Adults
Skin Disease, Immune System Disease
RecruitingPhase 1
Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function
Healthy Participants, Hepatic Impairment
RecruitingPhase 1
A Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics of Ammoxetine Hydrochloride Enteric-Coated Tablets in Participants With Moderate Renal Impairment and Normal Renal Function
Healthy Participants, Participants With Moderate Renal Impairment
RecruitingPhase 1
A Study to Learn How the Body Processes the Study Medicine Called Vepdegestrant in People With Loss of Liver Function
Healthy Participants
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.
John McRorie, PhD, FACG, AGAF study director
Procter and Gamble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zegerid® and Prilosec OTC® in people with Normal Healthy Subject Population, run by Procter and Gamble at 1 site in United States.
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 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 27 Apr 2011). 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?
The Mean Percent Time Gastric pH > 4.0 on Day 1 (time frame: continuously over a 24 hour period). 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 1 Jun 2015.