OsteoarthritisPhase 3NCT00367211
Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.
A Phase 3 study testing PN 200 tablets (500 mg naproxen and 20 mg omeprazole) and Naproxen 500 mg tablets (PN 200 minus omeprazole) in people with Osteoarthritis and Rheumatoid Arthritis, run by POZEN at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the incidence of gastric ulcers following administration of either PN 200 or Naproxen in subjects who are at risk for developing NSAID-associated ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
- What is being tested?
- PN 200 tablets (500 mg naproxen and 20 mg omeprazole) and Naproxen 500 mg tablets (PN 200 minus omeprazole)
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2007
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female subjects with a history of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 6 months who are 18-49 years of age and have a history of a documented, uncomplicated gastric or duodenal ulcer (a mucosal break of at least 3 mm in diameter with depth, without any concurrent bleeding, clot or perforation) within the past 5 years OR, who are 50 years of age and older (these subjects do not require a history of a documented, uncomplicated gastric or duodenal ulcer within the past 5 years).
- 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:
- Complete abstinence from intercourse for at least 14 days prior to first dose of study drug, throughout the study, and for 30 days after completion of the study
- Female sterilization or sterilization of male partner; or,
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- Hormonal contraception by oral route, implant, injectable, vaginal ring; or,
- 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.
- Each subject must be able to understand and comply with study procedures required of a subject and is able and willing to provide written informed consent prior to any study procedures being performed.
Who cannot join
- History of hypersensitivity to omeprazole or to another proton-pump inhibitor.
- History of allergic reaction or intolerance to any NSAID (including aspirin) and/or subject has a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps.
- Participation in any study of an investigational treatment in the 4 weeks before screening.
- Presence of uncontrolled acute or chronic medical illness, e.g. gastrointestinal disorder, diabetes, hypertension, thyroid disorder, depression and/or infection that would endanger a subject if they were to participate in the study.
- Gastrointestinal disorder or surgery leading to impaired drug absorption.
- Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion would endanger a subject if they were to participate in the study.
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- Schizophrenia or bipolar disorder.
- Use of any excluded concomitant medication (see Section 9.2).
- A recent history (in the past 3 months) suggestive of alcohol or drug abuse or dependence, including overuse/abuse of narcotics for management of pain.
- Serious blood coagulation disorder including use of systemic anticoagulants.
- Positive test result for H. pylori at screening.
- Baseline endoscopy showing any gastric or duodenal ulcer at least 3 mm in diameter with depth.
- Screening laboratory value for ALT, AST >2 times the upper limit of normal.
- Estimated creatinine clearance < 30 ml/min.
- Other than noted specifically, any screening laboratory value that is clinically significant in the investigator's opinion and would endanger a subject if they were to participate in the study.
- History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.
The purpose of this study is to evaluate the incidence of gastric ulcers following administration of either PN 200 or Naproxen in subjects who are at risk for developing NSAID-associated ulcers.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
- Being tested
- PN 200 tablets (500 mg naproxen and 20 mg omeprazole), Naproxen 500 mg tablets (PN 200 minus omeprazole)
- Keywords
- Gastric Ulcers, NSAID, Arthritis
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Stomach Ulcer, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN 200 tablets (500 mg naproxen and 20 mg omeprazole)Drug
Naproxen 500 mg tablets (PN 200 minus omeprazole)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable is the incidence of gastric ulcers, defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with depth, at anytime throughout 6 months of study treatment.
Secondary outcomes (1)
The secondary efficacy variable is the incidence of duodenal ulcers at any time throughout 6 months of treatment, tolerability and safety.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- POZEN
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367211
- Sponsor's protocol ID
- PN200-301
- Status last verified
- Apr 2008
- First submitted
- 18 Aug 2006
- Last updated
- 22 Apr 2008
- Results posted
- No
- 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
- A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.
- ClinicalTrials.gov ID
- NCT00367211
- Acronym / sponsor ID
- PN200-301
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
- Keywords
- Gastric Ulcers, NSAID, Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- POZENIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 22 Aug 2006 (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.
The purpose of this study is to evaluate the incidence of gastric ulcers following administration of either PN 200 or Naproxen in subjects who are at risk for developing NSAID-associated ulcers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or non-pregnant female subjects with a history of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 6 months who are 18-49 years of age and have a history of a documented, uncomplicated gastric or duodenal ulcer (a mucosal break of at least 3 mm in diameter with depth, without any concurrent bleeding, clot or perforation) within the past 5 years OR, who are 50 years of age and older (these subjects do not require a history of a documented, uncomplicated gastric or duodenal ulcer within the past 5 years).
- Female subjects are eligible for participation in the study if they are of:
- Each subject must be able to understand and comply with study procedures required of a subject and is able and willing to provide written informed consent prior to any study procedures being performed.
Key exclusion criteria (16 listed)
- History of hypersensitivity to omeprazole or to another proton-pump inhibitor.
- History of allergic reaction or intolerance to any NSAID (including aspirin) and/or subject has a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps.
- Participation in any study of an investigational treatment in the 4 weeks before screening.
- Presence of uncontrolled acute or chronic medical illness, e.g. gastrointestinal disorder, diabetes, hypertension, thyroid disorder, depression and/or infection that would endanger a subject if they were to participate in the study.
- Gastrointestinal 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 |
|---|---|---|
| PN 200 tablets (500 mg naproxen and 20 mg omeprazole) | Drug | – |
| Naproxen 500 mg tablets (PN 200 minus omeprazole) | Drug | – |
Primary outcome
The primary efficacy variable is the incidence of gastric ulcers, defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with depth, at anytime throughout 6 months of study treatment.
1 secondary outcome
The secondary efficacy variable is the incidence of duodenal ulcers at any time throughout 6 months of treatment, tolerability and safety.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PN 200 tablets (500 mg naproxen and 20 mg omeprazole) and Naproxen 500 mg tablets (PN 200 minus omeprazole) in people with Osteoarthritis and Rheumatoid Arthritis, 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 16 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 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?
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?
The primary efficacy variable is the incidence of gastric ulcers, defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with depth, at anytime throughout 6 months of study treatment.. 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.