HealthyPhase 4NCT00903448
Comparison of Prilosec Over-the-counter (OTC)® Versus Prevacid® for Gastric Acid Suppression
A Phase 4 study testing Prilosec OTC (omeprazole-magnesium) and Prevacid in people with Healthy, run by Procter and Gamble at 1 site in United States.
Trial summary
The objective of this study is to compare Prilosec OTC® to Prevacid® for 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
- Healthy
- What is being tested?
- Prilosec OTC (omeprazole-magnesium) and Prevacid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jun 2009
- 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 age 18-65
- generally healthy
- 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, lansoprazole 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
Official title: Comparison of Prilosec OTC® Versus Prevacid ® for Gastric Acid Suppression
The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid suppression.
- Conditions
- Healthy
- Being tested
- Prilosec OTC (omeprazole-magnesium), Prevacid
- Keywords
- Normal Healthy Subject Population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prilosec OTC (omeprazole-magnesium)Drug
Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast
PrevacidDrug
Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Prilosec OTC Receives: Drug: Prilosec OTC (omeprazole-magnesium) |
| B | Active comparator | Prevacid Receives: Drug: Prevacid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Time That Gastric pH > 4.0 on Day 5
for 24 hours starting Day 5 for each period
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2009
- Study completionJun 2009
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 HealthyStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Simon H Magowan, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903448
- Sponsor's protocol ID
- 2009010
- Status last verified
- Dec 2010
- First submitted
- 14 May 2009
- Last updated
- 31 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prilosec OTC® Versus Prevacid ® for Gastric Acid Suppression
- ClinicalTrials.gov ID
- NCT00903448
- Acronym / sponsor ID
- 2009010
- Conditions
- Healthy
- Keywords
- Normal Healthy Subject Population
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 May 2009 (estimated)
- Results
- Posted 22 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid suppression.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Prilosec OTC (omeprazole-magnesium)Prilosec OTC |
| B | Active comparator | Drug: PrevacidPrevacid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- normal subjects who are age 18-65
- generally healthy
- 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, lansoprazole 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 |
|---|---|---|
| Prilosec OTC (omeprazole-magnesium)Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast | Drug | A |
| PrevacidPrevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast | Drug | B |
Primary outcome
Mean Percent Time That Gastric pH > 4.0 on Day 5
Time frame: 24 hours
for 24 hours starting Day 5 for each period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2010.
- 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.
Simon H Magowan, MD 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 Prilosec OTC (omeprazole-magnesium) and Prevacid in people with Healthy, 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 3 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 31 Dec 2010. 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 22 Nov 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?
Mean Percent Time That Gastric pH > 4.0 on Day 5 (time frame: 24 hours). 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 31 Dec 2010.