HealthyPhase 1NCT00442208
An Open-Label, Randomized, Comparative 3-Way Cross-Over Study to Evaluate the Effect of Food on the 24-Hour Intragastric pH at Day 5 After Twice Daily Oral Administration of PN 200 (Omeprazole/Naproxen) in Healthy Volunteers
A Phase 1 study testing PN 200 in people with Healthy, run by POZEN at 1 site in United States.
Trial summary
Primary: To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH> 4.0) following twice daily administration at different dosing times relative to food (30 or 60 minutes prior to food or taken togeterh with food) on Day 5. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PN 200
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Feb 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-lactating, non-pregnant female subjects who are 18-55 years of age
- Female subjects are eligible for participation in the study if they are of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
- Childbearing potential, have a negative pregnancy test (urine) at screening, and at least one of the following applies or is agreed to by the subject:
- Female sterilization or sterilization of male partner; or,
- Hormonal contraception by oral route, implant, injectable, vaginal ring; or,
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- Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year;
- Double barrier method (2 physical barriers or 1 physical barrier plus spermicide); or
- Any other method with published data showing that the lowest expected failure rate is less than 1% per year
- Physical examination findings within normal limits for age
- Able to understand and comply with study procedures required and able and willing to provide written informed consent prior to any study procedures being performed
Who cannot join
- History of hypersensitivity, allergy or intolerance to omeprazole or other proton-pump inhibitors
- History of hypersensitivity, allergy or intolerance to any NSAID (including aspirin) and/or a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
- History of peptic ulcer disease or other acid related gastrointestinal symptoms
- Participation in any study of an investigational treatment in the 4 weeks 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
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- Any significant mental illness, such as schizophrenia or bipolar disorder
- Cardio- or cerebrovascular disease, based on history or risk factors, or clinically significant ECG in the investigator's opinion
- Personal or family history of an inherited or acquired bleeding disorder
- Positive test result for H pylori at screening
Trial locations and contacts
1 site in 1 country.
About this study
Primary: To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH> 4.0) following twice daily administration at different dosing times relative to food (30 or 60 minutes prior to food or taken togeterh with food) on Day 5.
Read the detailed description
This study is designed to evaluate the effect of different dosing times of PN 200 relative to food on the intragastric pH profile of PN 200. PN 200 contains immediate release omeprazole, which may be subject to acid degradation in the stomach. Food is known to have a buffering effect on acid and therefore may result in less degradation of immediate release omeprazole. Alternatively, food may decrease the absorption of omeprazole in the duodenum. The relative magnitude of these effects is unknown. The data from this study will aid in choosing the optimal timing of PN dosing relative to food in future studies. The study is not blinded because the primary endpoint (intragastric pH) is a physiological variable not believed to be readily influenced by conscious or subconscious subject control.
- Conditions
- Healthy
- Being tested
- PN 200
- Keywords
- Healthy adults, Phase I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN 200Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH > 4.0)
Secondary outcomes (1)
To evaluate the effect of different dosing times of PN 200 on the pharmacokinetic properties of omeprazole
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- POZEN
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Taylor, Study director, POZEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442208
- Sponsor's protocol ID
- PN200-105
- Status last verified
- Apr 2008
- First submitted
- 28 Feb 2007
- Last updated
- 22 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Comparative 3-Way Cross-Over Study to Evaluate the Effect of Food on the 24-Hour Intragastric pH at Day 5 After Twice Daily Oral Administration of PN 200 (Omeprazole/Naproxen) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00442208
- Acronym / sponsor ID
- PN200-105
- Conditions
- Healthy
- Keywords
- Healthy adults, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- POZENIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary: To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH> 4.0) following twice daily administration at different dosing times relative to food (30 or 60 minutes prior to food or taken togeterh with food) on Day 5.
Detailed description
This study is designed to evaluate the effect of different dosing times of PN 200 relative to food on the intragastric pH profile of PN 200. PN 200 contains immediate release omeprazole, which may be subject to acid degradation in the stomach. Food is known to have a buffering effect on acid and therefore may result in less degradation of immediate release omeprazole. Alternatively, food may decrease the absorption of omeprazole in the duodenum. The relative magnitude of these effects is unknown. The data from this study will aid in choosing the optimal timing of PN dosing relative to food in future studies. The study is not blinded because the primary endpoint (intragastric pH) is a physiological variable not believed to be readily influenced by conscious or subconscious subject control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or non-lactating, non-pregnant female subjects who are 18-55 years of age
- Female subjects are eligible for participation in the study if they are of:
- Physical examination findings within normal limits for age
- Able to understand and comply with study procedures required and able and willing to provide written informed consent prior to any study procedures being performed
Key exclusion criteria (10 listed)
- History of hypersensitivity, allergy or intolerance to omeprazole or other proton-pump inhibitors
- History of hypersensitivity, allergy or intolerance to any NSAID (including aspirin) and/or a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
- History of peptic ulcer disease or other acid related gastrointestinal symptoms
- Participation in any study of an investigational treatment in the 4 weeks 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
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 |
|---|---|---|
| PN 200 | Drug | – |
Primary outcome
To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH > 4.0)
1 secondary outcome
To evaluate the effect of different dosing times of PN 200 on the pharmacokinetic properties of omeprazole
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2008.
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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.
David Taylor study director
POZEN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PN 200 in people with Healthy, run by POZEN 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 11 inclusion and 10 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 22 Apr 2008. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH > 4.0). 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 22 Apr 2008.